Devices, methods, and kits for preparing cell suspension
The kit and apparatus streamline the preparation and application of cell suspensions by using labeled containers and visual indicators, addressing inefficiencies and errors in current methods to enhance treatment efficacy.
Patent Information
- Application Number
- JP2024179963
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2020-07-22
- Filing Date
- 2024-10-15
- Publication Date
- 2025-01-23
- Estimated Expiration
- 2041-06-30
AI Technical Summary
Current methods for preparing and applying cell suspensions for wound treatment are inefficient and prone to user errors due to the complexity of equipment and numerous components, leading to potential contamination and inefficiencies.
A kit and apparatus for preparing cell suspensions, featuring a housing with labeled containers and visual indicators to guide the user through the tissue processing method, ensuring accurate assembly and use of components for each step of the process.
The solution simplifies the preparation process, reduces user errors, and enhances the efficiency and sterility of cell suspension application, improving treatment outcomes by ensuring proper handling and application of cell suspensions.
Smart Images

Figure 2025011249000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention generally relates to devices, methods, and kits for processing cells, such as preparing a cell suspension. This relates to the field of [Background technology]
[0002] Applying the cell suspension to the tissue treatment site on the patient can be used to treat wounds (e.g., burns, chronic wounds, etc.). ), which can act as an effective treatment for skin diseases such as pigmentation disorders. Current methods of preparing a liquid and applying it to the skin surface can, for example, The number of similar tools required and the total number of components can lead to user error and inefficiency. Therefore, there is a need to improve cell suspension preparation techniques and equipment. It is being done. Summary of the Invention
[0003] In some embodiments, the kit for preparing a cell suspension includes an apparatus and a housing. The apparatus may define a first container and a second container. The apparatus includes a first label identifying a first container for use in a first portion of the tissue processing method; and a second label identifying a second container for use in a second portion of the tissue processing method. The housing may be configured to receive the device. The housing may include: A first set of components associated with a first portion of a tissue processing method. The first housing portion may include a first housing portion configured to accommodate a first The second house may include a first visual indicator associated with the label of the first house. The housing includes a second set of components associated with a second portion of the tissue processing method. The second housing portion may be configured to accommodate a second label on the device. It may also include an associated second visual indicator.
[0004] In some embodiments, a packaging system for an apparatus for preparing a cell suspension is provided. The stem may comprise a first housing portion and a second housing portion. The packaging may include a first container having a first label and a second container having a second label. The first housing portion may include a first set of electrodes associated with a first portion of a tissue processing method. The first housing may include a pair of recesses configured to receive the components. The marking portion includes a first visual indicator associated with a first label of the device. The second housing portion may include a second housing portion associated with a second portion of the tissue processing method. The second component may include a set of recesses configured to receive the set of components. The housing portion includes a second visual indicator associated with a second label on the device. It's okay to be.
[0005] In some embodiments, the device packaged in the housing is used to suspend cells in a cell suspension. The method for preparing the suspension includes providing a first label and a handheld device disposed adjacent to a first container of the device. and identifying a first match with a first visual indicator included in a first housing portion of the housing. In response to identifying the first match, removing the first housing portion from the first housing portion. Taking a first set of components and using the first set of components to A first portion of a tissue processing method associated with the container may be performed. A second label is disposed adjacent to the second container of the device and a second housing portion of the housing is disposed adjacent to the second container of the device. A second match with the included second visual indicator may be identified. In response to identifying the match, remove a second set of components from the second housing portion. a second set of components is used to perform a first tissue processing method associated with a second container; Alternatively, part 2 may be executed.
[0006] The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with any drawings will be available upon request and payment of the necessary fee. This is provided by the Patent Office. [Brief description of the drawings]
[0007] [Figure 1] FIG. 1 is a schematic block diagram of a kit for preparing a cell suspension according to one embodiment. [Diagram 2] FIG. 1 is a schematic diagram of a kit for preparing a cell suspension, according to one embodiment. [Diagram 3] FIG. 1 is a flow diagram of a method for preparing a cell suspension using an apparatus packaged in a housing, according to some embodiments. [Figure 4] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Diagram 5] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 6] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 7] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 8] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 9] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 10] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 11] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 12] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 13] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 14] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 15] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 16] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 17] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 18] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 19] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 20] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 21] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 22] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 23] FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Figure 24]FIG. 1 illustrates components of a kit for preparing a cell suspension, according to one embodiment. [Diagram 25] FIG. 1 is a perspective view of a preparation tray according to one embodiment. [Figure 26] FIG. 1 is a cross-sectional view of a preparation tray according to one embodiment. [Figure 27] FIG. 1 is a perspective view of a preparation tray according to one embodiment. [Figure 28] FIG. 1 is a cross-sectional view of a preparation tray according to one embodiment. [Figure 29] FIG. 1 is a perspective view of a preparation tray according to one embodiment. [Diagram 30] FIG. 1 is a cross-sectional view of a preparation tray according to one embodiment. [Diagram 31] FIG. 1 is a perspective view of a preparation tray according to one embodiment. [Diagram 32] FIG. 1 is a cross-sectional view of a preparation tray according to one embodiment. [Diagram 33] FIG. 1 is a perspective view of a preparation tray according to one embodiment. [Diagram 34] FIG. 1 is a cross-sectional view of a preparation tray according to one embodiment. [Diagram 35] FIG. 1 is a perspective view of a preparation tray according to one embodiment. [Diagram 36] FIG. 1 is a perspective view of a preparation tray according to one embodiment. [Figure 37] FIG. 1 is a perspective view of a preparation tray according to one embodiment. [Figure 38] FIG. 1 is a perspective view of a preparation tray according to one embodiment. [Figure 39] FIG. 2 is a partial cross-sectional view of a preparation tray according to one embodiment. [Diagram 40] FIG. 2 is a partial cross-sectional view of a preparation tray according to one embodiment. [Diagram 41] FIG. 2 is a partial cross-sectional view of a preparation tray according to one embodiment. [Diagram 42] FIG. 1 is a perspective view of a kit for preparing a cell suspension according to one embodiment. [Diagram 43] FIG. 1 is a perspective view of a kit for preparing a cell suspension according to one embodiment. [Diagram 44] FIG. 1 is a perspective view of a kit for preparing a cell suspension according to one embodiment. [Diagram 45] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Diagram 46] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 47] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 48] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 49] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 50] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 51] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 52] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 53] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 54] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 55] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 56] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 57] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 58] 13 is an image of a step of packaging a shipping kit according to one embodiment. [Figure 59] FIG. 2 is a top view of a portion of an apparatus for preparing a cell suspension, according to one embodiment. [Figure 60A]FIG. 2 is an exploded view of a housing (including a housing liner) of a kit for preparing a cell suspension according to one embodiment. [Figure 60B] FIG. 1 is a plan view of a housing (not including a housing liner) of a kit for preparing a cell suspension according to one embodiment. [Figure 61A] FIG. 1 is a perspective view of a base of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 61B] FIG. 1 is a rear view of a base of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 61C] FIG. 1 is a plan view of a base of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 61D] FIG. 1 is a front view of a base of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 61E] FIG. 2 is a bottom view of the base of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Fig.61F] FIG. 1 is a left side view of the base of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 61G] FIG. 1 is a right side view of a base of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 62A] FIG. 1 is a perspective view of an integrated tray portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 62B] FIG. 13 is a rear view of an integrated tray portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 62C] FIG. 1 is a plan view of an integrated tray portion of a kit for preparing and / or delivering a cell suspension, according to one embodiment. [Fig.62D] FIG. 1 is a front view of an integrated tray portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 62E]FIG. 1 is a bottom view of an integrated tray portion of a kit for preparing and / or delivering a cell suspension, according to one embodiment. [Fig.62F] FIG. 1 is a left side view of an integrated tray portion of a kit for preparing and / or delivering a cell suspension, according to one embodiment. [Fig.62G] FIG. 13 is a right side view of an integrated tray portion of a kit for preparing and / or delivering a cell suspension, according to one embodiment. [Figure 63A] FIG. 1 is a perspective view of a housing portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 63B] FIG. 13 is a rear view of a housing portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 63C] FIG. 1 is a plan view of a housing portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Fig. 63D] FIG. 1 is a front view of a housing portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 63E] FIG. 1 is a bottom view of a housing portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Fig.63F] FIG. 1 is a left side view of a housing portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. [Figure 63G] FIG. 13 is a right side view of a housing portion of a kit for preparing and / or delivering a cell suspension according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0008] In some embodiments, the kit for preparing a cell suspension includes an apparatus and a housing. The housing may comprise, for example, a housing for storing and / or transporting the device. The device may be adapted to function as device packaging for a tissue processing method. For example, the device may include a first container, and a second container. The apparatus may be used in the first part of the tissue processing method. a first label identifying the first container and a second container for use in a second portion of the tissue processing method. and a second label identifying the device. The housing is adapted to receive the device. The housing may be configured to include a first filter associated with a first portion of the tissue processing method. The first housing portion is configured to house a set of components. The first housing portion may include a first visual indicator associated with a first label of the device. The second housing portion may include a second housing portion associated with a second part of the tissue processing method. The second hardware may be configured to store a second set of components stored in the second hardware. The housing includes a second visual indicator associated with a second label on the device. Thus, in some embodiments, the first housing portion may be A first container is identified as including a first set of components associated with the first container. The first set of components and the first container of the device may be configured as Similarly, in some embodiments, wherein the second housing portion includes a second set of containers associated with a second container of the device. The second set of components may be identified as including A second container of components and an apparatus for use in a second part of the tissue processing method. Any suitable number (or numbers) of tissue may be added in a similar manner associated with other parts of the tissue processing method. For example, three, four or more housing sections and their respective containers are identified. In some embodiments, the method further comprises: Additionally or alternatively, corresponding labels and visual indicators may be provided to In a similar manner, the outer surface (e.g., surface) of the non-container device may be It is to be understood that may be labeled.
[0009] In some embodiments, a packaging system for an apparatus for preparing a cell suspension is provided. The stem may comprise a first housing portion and a second housing portion. The packaging may include a first container having a first label and a second container having a second label. The first housing portion may include a first set of electrodes associated with a first portion of a tissue processing method. A set of one or more recesses configured to receive one or more components. The first housing portion may define a first label associated with the device. A first visual indicator may be included (e.g., to indicate a first capacity of the device). to identify the first housing portion as including a component associated with the device; The first set of components and the first container of the device may be a tissue. The second housing part may be adapted for use in the first part of the treatment method. A second set of one or more components associated with a second portion of the tissue processing method. The second recess may define a set of one or more recesses configured to receive the second The housing portion includes a second visual indicator associated with a second label on the device. (e.g., to allow a component associated with the second container of the device to be The second housing portion may be identified as including a second component, and such a second The second set of components and the second container of the apparatus are used in a second part of the tissue processing method. (It may be possible to use similar methods associated with other parts of the tissue processing method. Any suitable number (e.g., three, four, or more) of housing parts and Each container may be identified and labeled. In embodiments, in addition or as an alternative, corresponding labels and visual indicators are provided. The outer surface of the non-container device may be coated with a coating material in a similar manner in association with one or more housing parts. It is to be understood that the object (eg, surface) may be labeled.
[0010] In some embodiments, the device packaged in the housing is used to suspend cells in a cell suspension. The method for preparing the suspension includes providing a first label and a handheld device disposed adjacent to a first container of the device. and identifying a first match with a first visual indicator included in a first housing portion of the housing. In response to identifying the first match, removing a first set of the first housing portion. A component is taken and associated with a first container using a first set of components. The apparatus may be adapted to perform a first part of a tissue processing method using a second container. A second label disposed adjacent to the device and a second housing portion of the housing A second match may be identified with the visual indicator of the first type. In response, remove a second set of components from the second housing portion and and performing a second portion of the tissue processing method associated with the second container using the components. In some embodiments, the method may be performed on any suitable number of Identifying matching of housing parts (e.g., three, four or more) with their respective containers and removing the components from these housings for use in tissue processing. and using the method in other parts of the method. In addition or instead, corresponding labels and visual indicators may be provided for In a similar manner, the outer surface of the non-container device (e.g., It is to be understood that the surface may be labeled.
[0011] Kits and devices for cell suspension FIG. 1 is a schematic diagram of a kit 100 for preparing a cell suspension. The kit 100 includes: The apparatus 110 includes a housing 120. The apparatus 110 may also be referred to as a processing unit. Generally, the device 110 may be used to perform a variety of tasks (e.g., preparing a cell suspension), as described in more detail below. Features for use in tissue processing methods (e.g., containers, preparation trays for tissue manipulation, etc.) ) may be included in the housing 120. of various components (e.g., tools) used in tissue processing methods involving The housing and the device may also function as a packaging. Such exemplary features are described in more detail below.
[0012] For example, the device 110 may include a first container 111 and a second container 113. The device 110 includes a first step for identifying a first container 111 for use in a first portion of the tissue processing method. A label 112 identifies the first container 113 and a second container 113 for use in a second portion of the tissue processing method. and a second label 114.
[0013] The housing 120 may be configured to receive the device 110. 120 may include a first housing portion 130 and a second housing portion 140. The first housing portion 130 includes a first part associated with a first portion of a tissue processing method. The second housing portion 140 may be configured to house the set of components. stores a second set of components associated with a second portion of the tissue processing method. The first housing portion 130 may be configured to receive the first label 112 of the device. The second housing may include a first visual indicator 132 associated with the second housing. The label 140 includes a second visual indicator 114 associated with the device's second label 114. One or both of the first and second housing portions may include a tissue processing Each is designed to accept a particular type of component (e.g., a tool) for use in the method. The recess may include a sized and shaped recess.
[0014] In some embodiments, the first housing portion 130 and the second housing portion 1 40 may be integrally formed as part of the integrated tray portion 150. In an embodiment, the housing 120 includes a first housing portion 130 and a second housing portion 130. a unified tray portion 150 configured to removably receive the packaging portion 140. The first housing portion 130 and the second housing portion 140 may be integral with each other. The integrated tray portion 150 may be formed integrally with the tray portion 150 or may be a separate tray portion. , to receive the first housing portion 130 and / or the second housing portion 140. In some embodiments, the recess may define one or more recesses. wherein the integrated tray portion 150 defines a recess configured to receive the device 110. It's fine.
[0015] In some embodiments, the first housing portion 130 and the second housing portion 1 40 may be removably coupled to one another. For example, in some embodiments In the embodiment, the housing portion 130 and the second housing 140 have a plurality of perforations. The first housing portion 130 is separated (e.g., torn) from the first housing portion 130 by separating (e.g., tearing) the first housing portion 130 from the second housing portion 130. The second housing part 140 is provided with a perforated connector so that it can be separated from the first housing part 140. As another example, in some embodiments, In some embodiments, one or more fasteners (e.g., adhesives, mechanical fasteners, etc.) and and / or a mating or interlocking mechanism (e.g., the first housing portion 130 is a first mating mechanism The second housing portion 140 may include a second mating mechanism, and the first and The second mating mechanism is snap-fit or removably coupled to the first mating mechanism. , the housing portion 130 and the second housing 140 may be coupled to one another.
[0016] In some embodiments, the housing 120 includes a third housing portion 160. The apparatus 110 may define a third container 115 and may also include a tissue processing and a third label 116 identifying a third container 115 for use in a third portion of the method. The third housing portion 160 may include a third housing portion associated with a third portion of the tissue processing method. 3. In an embodiment, the third housing portion 160 includes recesses for each of the third set of components. In some embodiments, the third housing portion 160 may define: The third set of components may define recesses in various components (e.g., For example, a single recess may be configured to receive a subset of common or identical components. The third housing portion 160 is associated with a third label 116 of the device. In some embodiments, the third visual indicator 162 may be included. , the third housing portion 160 (e.g., As mentioned above, the perforations can be separated (e.g., torn apart) to form a Thus, the third housing portion 160 is connected to the first housing portion 130 and / or the second housing portion 130. A perforated connecting portion is provided so that it can be separated from the housing portion 140. rtion) and / or through one or more fasteners, engagements, or interlocks via the mechanism) to the first housing portion 130 and / or the second housing portion 140 In some embodiments, the housing 1 may be removably coupled to the housing 1. 20 or any other suitable number (e.g., 2, 3, 4, 5, or more) The housing may include a housing portion for housing the device for use in each part of the tissue processing method. It is to be understood that each label on a face corresponds to a respective visual indicator.
[0017] In some embodiments, the housing 120 may be the first housing portion 1 shown in FIG. 30, second housing portion 140, and third housing portion 160. The base 170 may include a base configured to receive a first housing. A first housing portion 130, a second housing portion 140, and a third housing portion 160 In addition, the device 110 may be configured to receive the device 110. The base portion 170 is connected to the integrated tray portion 150 (e.g., the first housing portion 130, the second housing portion 140, the a housing portion 140, and an integrated tray portion 150 including the device 110, and a third The base portion 170 may be configured to receive the housing portion 160. For example, the base portion 170 may be configured to A first recess configured to receive the integrated tray portion 150 and a third housing portion 1 and a second recess configured to receive the nozzle 60. In some embodiments, the integrated tray portion 150 (first housing portion 130, second housing portion 130) The housing portion 140 includes the first housing portion 140 and the device 110, and the third housing portion 160 includes the second housing portion 160. Each of the integrated tray portions 15 can be individually removed from the base portion 170. 0 and device 110 can be easily and efficiently removed from the base and the third housing portion 160 The information may be stored in a separate area.
[0018] In some embodiments, the housing 120 includes a base 170 (e.g., an integral trough). A box in which a base portion 170 including a lay portion 150 and a third housing portion 160 can be disposed. The box 108 may comprise a housing 108 or other suitable enclosure. 1. A suitable enclosure that partially or completely encloses other portions of the ring 120 (e.g., a tray, etc.). It may include a cardboard that is folded and / or otherwise secured to the body. In some embodiments, the box 108 (or a box insert disposed therein) The vial recess 180 may define a vial recess 180. The enzyme may be placed in a vial, insert, or other structure. (e.g., an enzyme vial disposed in a sterile pouch) Enzymes are useful, for example, for chemically breaking down tissue, as explained in more detail below. In some embodiments, the housing 120 may include a first housing portion 13. 0, second housing portion 140, device 110, and an optional third housing A partition may be provided separating the vial recess 180 from the section 160. For example, A notch may separate the vial recess 180 from the base 170. For example, sterilization of other parts of the housing 120 (or at least the device 110) may be performed. Sterilization of the enzyme vial may be possible separately from the enzyme vial. Other parts of the housing 120 (e.g., device 110) may undergo a different sterilization process. Such a separate sterilization process may be used, for example, by using enzymes or or to avoid damage or other destruction of device 110. For example, some In an embodiment, the enzyme is at risk of being damaged when subjected to ethylene oxide sterilization. , while device 110 (which may include a processor and / or other electronic devices) ) may be at risk of damage when subjected to gamma radiation sterilization. The vial and device 110 each have respective sterilization and sterilization steps that reduce the risk of damage to the sterile components. For example, the electronics (e.g., of the device 110) may be subjected to a sterilization process. The portion of the housing 120 containing the vessel is sterilized (e.g., with ethylene oxide) in a first sterilization process. The enzyme vial is sterilized by the process while it is inserted into the vial recess 180 of the housing 120. are separately sterilized in a second sterilization process (e.g., by gamma irradiation) before being inserted into In some embodiments, the sterile enzyme vial is , may be placed in a sterilization pouch prior to being placed in the vial recess 180. And, prior to or as an initial step in the first part of the tissue processing method, the enzyme in the sterilization pouch is The blank vial is removed from the vial recess 180 and the enzyme vial is removed from the sterilization pouch. and the enzyme vial is placed in the first housing portion 130 along with the first set of components. (e.g., to a work space adjacent to or within the sterile field), The enzyme vial is disposed within an enzyme vial recess defined in the first housing portion 130. It may be possible to do so.
[0019] In some embodiments, the device 110 is adapted to be used to perform tissue processing methods. In particular, device 110 may include any suitable features or components. The apparatus 110 may include a skin tissue manipulation area surrounded by a side wall. The a may optionally include a textured surface area. In an embodiment, the device 110 is used to perform at least a portion of a tissue processing method (e.g., For example, a preparation method (used in the second and / or third parts of the tissue processing method) The preparation tray may be removed from a complementary recessed area of the device 110. (e.g., lifting or removing from a slot) Alternatively, in some embodiments, the preparation tray may be integral with the device 110. For example, the device 110 may be integrally formed as a region within the base structure of the device 110. Additionally, in some embodiments, the preparation tray may include one or more Snap-off connector pieces, perforations, releasable mating mechanism, removable The adhesive may be removably attached to the device 110 by a removable adhesive (e.g., tape) or the like. In some embodiments, the preparation tray comprises a skin tissue manipulation area and In some embodiments, the preparation tray comprises a skin tissue preparation tray. One or more of said preparation trays, each of which includes a processing area, disposed relative to the other portion of the bottom surface of said preparation tray. By including a collection area, the skin tissue manipulation area of the preparation tray can be separated from the collection area side and and / or into a collection area.
[0020] In some embodiments, the skin tissue manipulation area may be a smooth, flat surface. In some embodiments, the skin tissue manipulation area is a collection area (e.g., a filter 106) toward the third container 115, the third container 115 may include one or more depressions, ridges, It may include or define a slope, incline, or pathway (e.g., an outlet). In some embodiments, at least a portion of the preparation tray (e.g., skin tissue) The operation area) is (for example, by impregnating the skin tissue operation area with plastic injection molding Additionally or alternatively, the device may be at least partially formed of an antimicrobial material. At least a portion of the preparation tray (e.g., the skin tissue manipulation area) is coated with a coating on the surface of the preparation tray. For example, the preparation tray may include an antimicrobial coating applied thereto. one or more of the following: antihistamines, trimethoprims, quinolones, and / or nitrofurans As another example, the preparation tray may additionally or alternatively contain an antimicrobial agent. Bacterial nanotechnology or other antibacterial technologies (e.g., silver nanoparticles, phenols, polybiguanides ( For example, polyhexamethylene biguanide (PHMB), chitosan, and / or halo. As another example, the preparation tray may include a halamine (e.g., an N-halamine). , in a coating, by attachment via bonds (e.g., covalent bonds, ionic bonds), and / or by matrix Intravenous, one or more antibiotics (e.g., minocycline, rifampin, (e.g., ceftazidime implant, gentamicin implant, etc.) As another example, the preparation tray may additionally or alternatively include one or more Any number of other suitable bacteriostatic or other antimicrobial coatings or materials (e.g., organosiloxanes As another example, the preparation tray may additionally or alternatively include impregnation and and / or contain one or more disinfectants (e.g., chlorhexidine) Further, the preparation tray may additionally or alternatively be provided with a One or more precious metals (e.g., silver salts, ions) incorporated and / or coated therewith , complexes, and / or nanostructures of silver, gold, copper, or palladium, etc. Additionally or alternatively, the preparation tray may be inoculated with one or more antibiotics or other antimicrobial agents. Such as methylene blue and / or phenothiazines that act synergistically with It may also contain (by impregnation and / or coating) one or more non-antibiotics.
[0021] In some embodiments, the device 110 is configured to heat the contents of the first container 111. The heating assembly may include any suitable heating assembly configured as follows: A heating mechanism, an energy storage device, an indicator light (e.g., LED), or may have multiple activation buttons and / or associated electronics. For example, the heating assembly may be configured to be activated by pressing a button on the heating assembly. The heating assembly may be configured to allow the heating mechanism to heat the device to a target temperature or range of temperatures. configured to illuminate a first indicator light during a first period of time during which heat is being delivered; In some embodiments, the heating assembly may be configured to heat the heating mechanism to a target temperature or A second indicator light is illuminated during a second period of time when the device is operating within the target temperature range. In some embodiments, the heating assembly may include a first container 111 and / or Alternatively, the second inlet is heated while the contents of the first container 111 are at the target temperature or within the target temperature range. In some embodiments, the heating assembly may include a heating indicator light. The assembly is configured to operate the heating mechanism to keep the contents of the first container 111 at a target temperature or within a target range. By turning on the first indicator light to show that the The first indicator light may be turned on and off periodically or intermittently. The heating assembly maintains the temperature of the first container 111 at a constant temperature for a first period of time (e.g., 15 minutes, 20 The first period may be configured to be maintained for a period of time (for example, 10 minutes, 20 minutes, or 60 minutes). The heating assembly then increases the temperature to the target temperature for a second period of time (e.g., 15 minutes). Alternatively, the device may be configured to maintain the concentration within a target range. and the heating assembly generates an audible indication at periodic intervals (e.g., once per minute) during the second period. The device may include an alarm (eg, an audible alarm) configured to provide a In some embodiments, after the first period or the second period, the heating assembly The operation of supplying heat to the first container 111 may be automatically stopped.
[0022] In some embodiments, the first set of components is a volume of water (e.g., For example, a vial containing sterile water, a needle, and / or an enzyme syringe. For example, the syringe may be a 10 ml or any suitable volume syringe. The syringe may be adapted to be coupled to the syringe (e.g., by a snap fit, threaded connection, other suitable fasteners, etc.). In some embodiments, the first set of components may be configured as follows: In some embodiments, the first set of components may include a cell strainer. The components may include an enzyme vial. The first housing portion 130 includes a first associated with each of the components in the first set, and The recess may define a shape complementary to the recess.
[0023] In some embodiments, the second set of components includes buffer vials. The device may include a ffer vial, a needle, and / or a buffer syringe. In an embodiment, the second set of components includes a first buffer vial, a second buffer vial, A vial, a needle, a first syringe (e.g., a syringe intended for transferring a buffer), a second syringe (e.g., a syringe intended for the transfer of unfiltered suspensions), and two surgical The first syringe and the second syringe may each contain, for example, a 10 ml Or it may be a syringe of any suitable capacity. The filling needle may be, for example, a blunt filling needle. The first buffer vial may be a needle. The scalpel may be disposable. The second buffer may contain, for example, 10 ml or any suitable volume of buffer. The vial may contain, for example, 30 ml or any suitable volume of buffer. The second housing portion 140 may house a second set of components, each of which may be a single component. a subset of the components in a second set, each of which is associated with the same The recess may be shaped to complement the shape of a subset of the components. .
[0024] In some embodiments, the third set of components includes a buffer vial, a filter, and a filter cartridge. a cyst filter, a set of skin cell syringes, a set of needles, an unfiltered suspension syringe, a set of spray nozzles, and a pair of scalpels. For example, a set of skin cell syringes may include four skin A cell syringe (e.g., a 10 ml syringe) may be included. A set of needles may include four or The set of injection needles may include any suitable number of needles (e.g., blunt filling needles). The mist nozzle may include four spray nozzles. Each skin cell injector may include (e.g., (One-handed operation) one of a set of needles or, alternatively, one of a set of spray nozzles The buffer vial may be, for example, 30 ml or any other suitable volume. In some embodiments, a third set of components may include a product buffer. The component may include a set of skin cell syringes, a set of needles, and a set of spray nozzles. The third housing portion 160 may house the second set of components, or the same components. a subset of the components in a second set, each of which is associated with the same The recess may be shaped to complement the shape of a subset of the components. .
[0025] The visual indicators on the housing 120 and the labels on the exterior of the device 110 may be any suitable In some embodiments, the first label 112 and The first visual indicator 132 and the second visual indicator 133 both have the same alphanumeric character, such as "A" (e.g., In some embodiments, the first laminae may include 1, 2, 3, etc. Both the bell 112 and the first visual indicator 132 may be in addition or alternative to the above. and contains the same color (e.g., red, orange, yellow, green, blue, purple, etc.), such as blue. In some embodiments, the first label 112 and the first visual indicator Any of the sensors 132 may additionally or alternatively display geometric symbols (e.g., circles, ellipses, etc.). shapes, triangles, squares, rectangles, etc.), punctuation marks, or other unique symbols (e.g., wavy lines, In some embodiments, the first line may include the same symbol (e.g., zigzag line). Both the bell 112 and the first visual indicator 132 may be displayed using letters, colors, numbers, and and / or may contain the same combination of symbols.
[0026] Similarly, in some embodiments, the second label 114 and the second visual indicator The indicator 142 is positioned above the first label 112 and the first visual indicator 132. As described above, the text may contain the same alphanumeric characters, colors, and / or symbols. For example, the second label 114 and the second visual indicator 142 may both include the same alphanumeric text. In some embodiments, the second label 1 may include a letter (e.g., B). Both the first visual indicator 14 and the second visual indicator 142 include the same color (e.g., gray). In some embodiments, the second label 114 and the second visual Both indicators 142 include the same symbol. In some embodiments, the second Both the label 114 and the second visual indicator 142 may be A common letter, color, number, or symbol on the bell 112 and the first visual indicator 132 contains the same combination of letters, colors, numbers, and / or symbols (different from
[0027] Similarly, in some embodiments, a third label 116 and a third visual indicator The indicator 162 is as described above with respect to the first label 112 and the first indicator 132. may contain the same alphanumeric characters, colors, and / or symbols as the The third label 116 and the third visual indicator 162 both have the same alphanumeric characters (e.g. For example, C). In some embodiments, the third label 116 and The first and second visual indicators 162 both include the same color (e.g., green). In some embodiments, the third label 116 and the third visual indicator All of the counters 162 may contain the same number (e.g., 3). In an embodiment, both the third label 116 and the third visual indicator 162 are In some embodiments, the third label 116 and and the third visual indicator 162 (e.g., the first label 112 and Unlike the common letters, colors, numbers, or symbols of the first visual indicator 132, the second The label 114 and the second visual indicator 142 may have a common letter, color, number, or inscription. may contain the same combination of letters, colors, numbers, and / or symbols (different from the stomach.
[0028] Any of the visual indicators described herein may be provided on each exterior surface of the device 110 (e.g., Process the corresponding housing parts (each exterior surface labeled similarly) and / or tissue The housing section (and the components contained therein) corresponds to each part of the method. Texture features or patterning (e.g., bumps, wells, It is to be understood that the recesses may have other suitable configurations, such as recesses, ribs, recesses, etc. Alternatively, some or all of the components contained in the housing may be integrated into each of the devices 110. Separately identified as corresponding to each part of the method of treating the surface and / or tissue. For example, some or all of the components may be mounted in a housing. As mentioned above for the parts (e.g., visual indicators such as alphanumeric characters, colors, symbols, textures, etc.) The device may include a handle labeled with a display indicator.
[0029] In some embodiments, at least a portion of the housing 120 (e.g., a recess The housing part (including the housing part) is at least partially injection molded, milled, or 3D printed. The housing 1 may be formed through other suitable processes such as folding, folding, etc. At least a portion of 20 is made of a suitable rigid or semi-rigid material (e.g., plastic, metal, For example, the first housing portion 130, the second housing portion 130 may include a a third housing portion 160; an optional integrated track The lay portion 150, the optional base portion 170, and the optional box 108 Each may be made of any suitable material. For example, the first housing part 1 30, second housing portion 140, and third housing portion 160 each have a positive The device may be made of a material such as a transparent or translucent plastic. The tray portion 150 and the base 170 are each made of plastic (e.g., a translucent plastic The box 108 may be made of cardboard or It may also be made of other suitable rigid or semi-rigid materials. In the case of One or more of the components may be sterile.
[0030] FIG. 60A and FIG. 60B are diagrams illustrating a kit for preparing and / or applying a cell suspension. 1 is a detailed view of an exemplary embodiment of a packaging system. 60A and 60B show a base, integral tray section (with visual indicators "A" and "B" ", as well as the first and second housing parts with a device recess, and 1 illustrates an exemplary assembly of a housing including a third housing portion with indicator "C." The first, second and third housing parts are each used for preparing a cell suspension and / or First, second, and third compositions for use in the first, second, and third portions of the method for application The first component includes recesses for receiving various components with a snap fit. and a housing liner configured to be disposed above the second housing portion. FIG. 60B is an exploded view of the assembly with the housing liner removed. This shows the
[0031] 61A-61G are diagrams illustrating the exemplary housing assembly shown in FIGS. 60A and 60B. Specifically, Figs. 61A to 61G show the base of the cell suspension in detail. 1 shows a perspective view, a rear view, a top view, and a front view of a base of a kit for preparing and / or dispensing a liquid; 1A is a bottom view, a left view, and a right view.
[0032] 62A-62G are diagrams illustrating the exemplary housing assembly shown in FIGS. 60A and 60B. 62A to 62G show the integrated tray portion in detail. 1 is a perspective view of an integrated tray portion of a kit for preparing and / or delivering a cell suspension; 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J, 1J, 1K, 1K, 1L, 1K, 1K, 1J, 1K ...
[0033] 63A-63G are diagrams illustrating the exemplary housing assembly shown in FIGS. 60A and 60B. Specifically, Fig. 63A-Fig. 63B show the third housing part in detail. 1 is a perspective view of a third housing part of a kit for preparing and / or delivering a cell suspension, respectively. 1A to 1C are front, rear, top, front, bottom, left and right views.
[0034] Methods for preparation and application of cell suspensions By using the kits and devices as described above, a method for preparing and applying a cell suspension can be The present invention may also be adapted to perform tissue processing methods such as the method of An example of the form will be explained.
[0035] As described above, the tissue processing method includes a first part, a second part, and an optional third part. The first, second and third parts of the tissue processing method may include Before performing one of the above, the user may detach the first housing portion 130, the second housing portion 130, The third housing section 140 and the optional third housing section 160 are For example, a user may be able to identify whether a particular portion of a document is associated with the document. To do this, a first label 112, a second label 114, and a third label 116 and the first visual indicator 132, the second visual indicator 142, and and at least partially identifying a match with one of the first and second visual indicators 162. For example, the user may view the device 110 and associate it with a first container 111. After identifying the attached first label 112, the first housing portion 130, the second housing portion 130, a corresponding first visual indicator in the third housing portion 160; The first visual indicator 132 may be located in the first housing. By identifying the first housing portion 130 as being associated with the first housing portion 130, the user A first part of the tissue processing method is performed using a first set of components stored in the recess of the A similar procedure may be followed for the second container 113, and then the second container 1 13, a second visual indicator 142 corresponding to a second label 114 associated with By identifying that the second housing portion 140 includes A second set of components stored in the recess of the tissue processing apparatus is used to perform a second part of the tissue processing method. A similar procedure may be followed for the third container 115, and then the third container 1 15, a third visual indicator 162 corresponding to a third label 116 associated with the By identifying that the third housing portion 160 includes A third set of components stored in the recess 60 is used to perform a third part of the tissue processing method. Alternatively, the timer may start at 10:00.
[0036] In some embodiments, the first part of the tissue processing method comprises the step of: preparing an enzyme mixture and delivering the enzyme mixture to a first container 111. For example, the first housing portion 130 may be configured to be inserted into a desired working space (e.g., For example, from the box 108 and / or the integrated tray portion 150 to or near the sterile field. The enzyme vial cover may be moved to the enzyme vial cover of the first housing part. Remove the vial from the recess and optionally clean the diaphragm of the vial with sterile alcohol. It may be wiped dry. (For example, the first set of components The first set of components may include a syringe having a first (second) needle fluidly coupled to the syringe of the first set of components. the needle of the component (e.g., of the first set of components) into a water vial A volume of water (e.g., the entire volume of the water vial) is drawn from the water vial into the syringe. A volume of water (e.g., the entire volume of water in the syringe) may be pumped from the syringe. After pouring the enzyme into the enzyme vial from the inside, it is left to stand until the enzyme dissolves in water to form the enzyme mixture. Mixing may be performed without shaking (e.g., to avoid foaming). The enzyme mixture may then be drawn back into the syringe. The enzyme mixture is then added to the first The syringe and needle may be discarded.
[0037] In some embodiments, the second part of the tissue processing method comprises a buffer for the tissue processing method. To prepare a buffer (e.g., by withdrawing a volume of buffer from a buffer vial) and delivering the second set of components to the second container 113. Even though a subset of In the sterile field, empty buffer injections (e.g., of the second set of components) The injector may optionally be marked "Buffer" and may be an empty, unfiltered suspension injector. The launcher (e.g., if included in the second set of components) may optionally be labeled “unfired.” The unfiltered suspension syringe may be marked "filtered suspension." In an embodiment included in the second part of the tissue processing method, the unfiltered suspension is In non-sterile preparation areas, covers (e.g., a second set of Remove the buffer vial (of the component) and remove the diaphragm of the buffer vial. Optionally, it may be wiped dry with a sterile alcohol wipe. In the second set of components, a needle is connected to a buffer syringe. In non-sterile preparation areas, users of the sterile field may A buffer vial may be provided to allow for the withdrawal of a desired volume of buffer. The user may place the free end of the needle inside the buffer vial, which may be convenient in some cases. A volume of buffer (e.g., the entire volume of buffer) may be drawn into the syringe. In the experiment, a volume of buffer was dispensed into the second container 113 of the device 110. Alternatively, the syringe with the needle attached may be set aside in the sterile field.
[0038] In some embodiments, the third part of the tissue processing method comprises delivering the cell suspension to the patient. 2. Preparing the cells (e.g., disaggregating a skin sample and preparing cells from the disaggregated skin sample) and drawing the cell suspension into a skin cell syringe. A set of skin cell syringes (e.g., from a third set of components) may be For example, four skin cell syringes), a set of needles, and a set of spray nozzles (for example, a third in the first housing section 160 or after removal from the third housing section 160) The patient's wound bed may be prepared. The wound bed is cleaned (e.g., by rotary diamond head deburring, laser ablation, etc.) Alternatively, prophylactic angioplasty (by sharp ablation, or other alternative techniques) may be performed. Optional administration of a suitable antibiotic and / or tissue processing method or procedure. Pre-infection of the wound may be performed. Remove all necrotic tissue and eliminate any pinpoint bleeding. Patients may be observed to develop pinpoint bleeding at the donor site. Next, a skin sample may be extracted from the donor site. The skin sample may comprise approximately The skin sample may be a thin split-thickness skin sample having a thickness of 0.15 to 0.20 mm. In some embodiments, a dermatome or may use a similar device.
[0039] In some embodiments, the area of the skin sample is used to estimate the cell suspension volume and / or For example, in some embodiments, the area of skin treatment may be correlated to the area of skin treatment. A 1 cm2 skin sample was prepared using Kit 100 for the preparation of a cyst suspension. One milliliter of cell suspension may be produced from Approximately 10cm 2 ~Approx. 100cm 2 , approximately 25 cm 2 ~Approx. 100cm 2 , and 50cm 2 ~Approx. 100cm 2 , or a maximum of approximately 25 cm 2 , maximum approximately 50cm 2 , maximum approximately 75cm 2 , or a maximum of approximately 100 cm 2 to be placed in the treatment area of For example, in some embodiments, 1 milliliter of cell suspension may be Up to approximately 80cm 2 (For example, allowing for a maximum expansion ratio of approximately 1:80) Therefore, the area of 6 cm 2 Approximately 6 ml from a skin sample Each kit contains up to four 6 cm 2Skin Samples may be processed to produce up to 24 ml of cell suspension. A 24 ml cell suspension can reach a maximum of approximately 1,920 cm 2 It can be used to treat a treatment area of For example, Table 1 shows the results obtained for treating various treatment area sizes using kit 100. These are just a few examples, including the size of the skin sample.
[0040] [Table 1]
[0041] Using the apparatus 110, the enzyme mixture in the first container 111 (e.g., the apparatus 110 described above) is For example, the device 110 may be heated by an activation button. Pressing the button may initiate heating of the enzyme mixture in the first container 111 . When the enzyme mixture is heated to the target temperature, a first light indicator (e.g., orange The enzyme mixture will reach the target temperature. A second light indicator (e.g. a green confirmation light) will be illuminated when In some embodiments, heating the enzyme mixture to a target temperature may include This may be accomplished for approximately three minutes or any other suitable period of time. In an embodiment, the first light indicator indicates the need for heating to maintain the temperature of the enzyme mixture. The light flashes briefly to indicate that the device is being activated intermittently or periodically. Good too.
[0042] One or more skin samples (e.g., each 6 cm 2 Has the following sizes The two skin samples are placed in a first container 111, and the enzyme mixture is allowed to react with the protein-protein interactions. The enzyme mixture may be heated for a first period of time to degrade the enzyme. The first period may be, for example, about 15 minutes to about 20 minutes. The larger the sample, the longer the incubation period (e.g., up to 60 minutes). In some embodiments, the 5 min, 10 min, 15 min, 20 min, 3 min, 0 minutes, etc., so that an audible and / or visual alarm on device 110 provides notification. Additionally or alternatively, after completion of the first period (e.g., approximately 1 Audio and / or visual alarms at different frequencies (every 5 minutes to about 20 minutes) After providing the signal, the periodic interval (e.g., every minute, every 5 minutes) is indicated over a second period. After a certain period of time (e.g., 15 minutes, 30 minutes, 60 minutes, etc.) In this case, the device 110 is shut down so that the heating assembly stops heating the enzyme mixture. Examples of auditory alarms include sound effects (beeps, tones, etc.); Voice prompts (e.g., "15 minutes") and voice instructions (e.g., "Sa Examples of visual alarms include "sample taken" or "sample confirmed." may include activating lights (e.g., LEDs) and sending text messages (e.g., on device 110). Alarms conveying these notifications may take any suitable form (e.g., audio, , visual, tactile, etc.) and / or third party devices that provide notifications. The information is transmitted to a device (e.g., a monitor screen, a mobile computing device) It is understood that this may also be done.
[0043] In some embodiments, at least a portion of the second part of the tissue processing method is performed using a tissue processing For example, the first container 111 may be subjected to the second part of the process simultaneously with the third part of the process. While the skin sample is being incubated in the enzyme mixture, a buffer is delivered to the second container 113. It may be arranged so that
[0044] Remove the skin sample from the heated enzyme mixture and place it dermis side down in the preparation of the device 110. For example, the third set of components may be placed on a sterile tray. Using a scalpel or scalpel, remove the skin sample from the first container 111 and place it in a preparation tray. The epidermal edge of each skin sample may be lightly scraped with a scalpel to remove cells. Degradation (eg, whether the epidermal cells are easily detached) may be tested. If the cells break down, scraping may be terminated. If the cells do not break down, the skin The sample is returned to the heated enzyme mixture for a period of time (e.g., approximately 5-10 minutes). Afterwards, the cells were removed and subjected to additional scraping tests to determine whether the cells had decomposed. If the cells can be scraped freely, the skin sample is placed in a second container 113. The skin sample may then be immersed in a buffer to wash off any residual enzyme mixture remaining on the skin sample. In addition, after passing the degradation test, a second cultured skin sample may be cultured in a second container, if necessary. The third skin sample and / or the fourth skin sample may be placed in a container 113. If a pool is desired, the first and second skin samples in the second container 113 are During the washing of the skin, the third skin sample and the fourth skin sample are respectively placed in the first container 111 and immersed in the enzyme mixture.
[0045] A second set of components (e.g., of a third set of components) from a second buffer vial A volume of buffer may be drawn into the buffer syringe of the component. A volume of buffer may contain, for example, 100 mg / cm2 of the first skin sample. Add approximately 1 ml of buffer plus an additional amount to account for losses during processing (e.g., approximately 0.5 ml Table 2 shows the syringe volume and skin sample size. Starting buffer volumes and resulting suspension outlines for various treatment surface area sizes As noted above, in some embodiments, one milliliter of cells The suspension is approximately 10 cm 2 ~Approx. 100cm 2 , approximately 25 cm 2 ~ approx. 100c m 2 , approximately 50 cm 2 ~Approx. 100cm 2 , or a maximum of approximately 25 cm 2 , maximum and 50cm 2 , maximum approximately 75cm 2 , or a maximum of approximately 100 cm 2 The treatment area is In some embodiments, 1 ml of suspension may be dispensed at up to 80 m 2 (e.g., allowing for a maximum expansion ratio of approximately 1:80) In some embodiments, the volume of cell suspension applied may be For example, in some embodiments, for spraying, 2 m As another example, a suspension volume of 1 or more may be applied to the treatment area. In embodiments, when using the drop technique, less than 1 ml of suspension volume is applied to the treatment area. It may be arranged to do so.
[0046] [Table 2]
[0047] Remove the skin sample from the second container 113 (e.g., dermis side down) and prepare A few drops of buffer from a buffer syringe may be added to the skin sample. The skin sample may be clamped using forceps or other suitable device. The surface of the epidermis may be lightly scraped with a scalpel blade. Once in the cell suspension, rub more vigorously until the remaining dermis is nearly disintegrated. The first syringe may be inserted so that the cell suspension can be collected in the collection area of the preparation tray. The buffer remaining in the tray may be used to clean the scalpel and tray. When the apparatus 110 containing the tray is placed on a horizontal surface, it may be underneath other areas of the tray. The cell suspension may be allowed to collect in the corners of the tray. If necessary, tilt the tray. The cell suspension may be accumulated in the corners by rotating the tray. Exemplary features of embodiments (e.g., texture features, height features, etc.) are described below. The buffer syringe may be saved for later use.
[0048] The cell suspension is drawn into an unfiltered suspension syringe (e.g., of the third set of components). After the cell suspension has been mixed, it may be delivered to a preparation tray to wash the preparation tray. By repeatedly lifting, delivering and washing the tray, cells are collected to the maximum extent possible. At least a portion (e.g., substantially all) of the cell suspension is then filtered. If not already in the third container 115, the suspension may be drawn into the syringe. For example, a cell strainer (of the third set of components) may be placed in the third container 115. The cell suspension may be filtered from the unfiltered suspension syringe through the cell strainer into the third container 115. The cell filter may be used to dispense the cell suspension onto the treatment surface. To prevent blockages, etc., the filter size is set to be suitable for removing large particles. For example, in some embodiments, the cell strainer may be less than about 200 μm. Filter sizes less than approximately 150 μm, less than approximately 100 μm, less than approximately 50 μm; or other suitable filter size. The unfiltered suspension syringe remains Any skin samples obtained may be saved in the sterile field for later use in conjunction with After the cell suspension has been passed through the cell strainer, the cell strainer is removed from the third container 115. Optionally, the cell strainer may be tapped above the third container 115. may cause any droplets of the cell suspension to be expelled into the third container 115. If the cell suspension becomes clogged (e.g. when processing multiple skin samples), Draw the cell suspension back from the filter into the unfiltered suspension syringe (e.g., another kit 100 A new cell strainer (from another vessel) may be placed in the third vessel 115 to perform additional filtration. It can also be.
[0049] (e.g., a third set of components) The filtered cell suspension in the third container 115 may be connected to a skin cell syringe (not shown). The suspension may be drawn into the skin cell syringe. The third container 115 contains the filtered cells. For collecting the suspension and drawing the filtered cell suspension into a needle attached to a skin cell syringe The filter may be shaped to include a conical bottom that is useful for later application of the filtered cell suspension to the treatment surface. You may save the skin cell syringe for use in the following procedure: Scraping the skin sample to extract skin cells Producing an unfiltered suspension and washing the tray to maximize cell collection and passing the cell suspension through a filter. A third set of components is a skin cell syringe, and a skin sample is drawn into the syringe. The procedure may be repeated every 20 minutes to generate a skin cell syringe of filtered cell suspension.
[0050] In some embodiments, the filtered cell suspension may be applied to a therapeutic surface (e.g., a wound bed, a colored preparing one or more dressings prior to delivery to the site of the Each dressing may be cut to the appropriate shape and / or size, and Prior to application of the cell suspension, a cellular adhesive (e.g., surgical glue) may be applied to the underside or adjacent to the treatment surface. , sutures, or staples) to provide a barrier from the treatment surface. The cell suspension may then be applied to the treatment surface. In some embodiments, the cell suspension is applied directly to the localized wound. Alternatively, it may be combined with a meshed autograft for application to full-thickness wounds. Good too.
[0051] The application of the prepared cell suspension to the therapeutic surface of the patient can be accomplished in a variety of ways. For example, depending on the volume of cell suspension to be applied and the size of the treatment surface, It may be sprayed or dripped onto the surface to be treated. The skin cell syringe may be inverted multiple times to ensure an even application of the suspension.
[0052] For spray application of the cell suspension, remove the needle from the skin cell syringe containing the cell suspension. Instead of needles, a set of nozzles (e.g., of a third set of components) may be used. One of the mist nozzles may be coupled to the skin cell syringe. The mist nozzle may be configured to spray the suspension orienting the device toward the treatment surface in a position such that an initial drop may be applied to the treatment surface; It may be located above the treatment surface (e.g., approximately 10 cm from the highest point of the treatment surface). Apply pressure to the plunger of the skin cell syringe to inject the cell suspension into the treatment surface. Spray on the highest part of the treatment surface so that any spill will cover the lower areas of the treatment surface. The cell suspension may be sprayed onto the treatment surface as a fine mist. For large treatment areas, when spraying, use a continuous motion from one side to the other with the sprayer (e.g. The combination spray nozzle and skin cell injector may be moved.
[0053] For dropwise application, the needle may be left in the skin cell syringe containing the cell suspension. In some embodiments, the cell suspension is applied to the treatment surface, starting at the highest point of the treatment surface. Drip gently so that any spillage covers low areas of the treatment surface. .
[0054] After application of the cell suspension, the treatment area is covered with one or more dressings. The dressing may be a non-adherent, non-absorbent and / or porous dressing. In some embodiments, the dressing is soaked in sterile saline prior to covering the treatment surface. The dressing may be secured with surgical adhesive, sutures, or staples, or The primary bandage may be secured to the treatment surface by other suitable fasteners. The secondary dressing should be moderately absorbent, minimally adhesive, low shear, and easily removable. The secondary dressing may be overlaid with absorbent gauze.
[0055] In some embodiments, the kit 100 includes a vial cap, a needle sheath, and / or may include a mechanism configured to allow removal of the syringe cap. For example, the kit 100 may include a bottle opener. When the pull tab is pulled, the seal of the housing 120 breaks and the inside of the packaging layer is exposed. A pull-down mechanism is provided for connecting the removable seal to the packaging layer to provide access to the removable seal. The packaging layer may include an integral protective packaging layer that includes a viewing tab. It may have a window (e.g., a transparent area that allows the user to see inside the packaging) The packaging layer may also include instructions for use (e.g., instructions for use on the packaging (It may be molded into the packaging layer or printed on the packaging layer.) In one embodiment, the base portion 170, the integrated tray portion 150, and the first housing portion 130 , the second housing portion 140, and / or the third housing portion 160 may include an integral protective Packaging layers and / or integrated protective packaging layers It is possible that you may be surrounded.
[0056] FIG. 2 is a schematic diagram of an exemplary kit 200 for preparing a cell suspension. 00 may be identical or similar in structure and / or function to kit 100 described above. For example, the kit 200 includes a housing 220 and a device 210. may be identical in structure and / or function to the housing 120 and the device 110, respectively. The housing 220 includes a box 208, a first housing portion 230, and a second housing portion 230. , second housing portion 240, third housing portion 260, and integrated tray portion 250. These include the box 108, the first housing portion 130, and the , second housing portion 140, third housing portion 160, and integrated tray portion 150. For example, the housing 22 may be the same or similar in structure and / or function as the housing 22. 0 optionally includes a vial recess 280 configured to receive a vial 282 Vial 282 may contain an enzyme (e.g., trypsin, trypsin- EDTA, dispase, collagenase, thermolysin, pronase, hyaluronidase , pancreatin, elastase, papain, etc. to dissociate the cell layers in skin tissue samples The first housing portion 230 may also include a first optical The second housing portion 240 includes a second visual indicator 232. 242 and the third housing portion 260 includes a third visual indicator 262 . The first visual indicator 232, the second visual indicator 242, and the third visual indicator Each of the target indicators 262 may be equipped with a corresponding one of the indicators 262 in a manner similar to that described above with respect to the kit 100 of FIG. 210. It is structured as follows:
[0057] As shown in FIG. 2, a first set of components associated with a first portion of the tissue processing method is A component 231 may be disposed in the first housing portion 230, and a second component 231 may be disposed in the first housing portion 230. A second set of components 241 associated with the second housing portion 240 a third set of components associated with a third portion of the tissue processing method. A component 261 may be disposed in the third housing portion 260 .
[0058] The first set of components 231 includes a water bottle containing a volume of water (e.g., sterile water). The catheter includes a catheter 233, a needle 234, and an enzyme syringe 235. For example, the enzyme syringe 235 The syringe 234 may be a 10 ml syringe. The needle 234 is adapted to be coupled to the enzyme syringe 235. As shown in FIG. 2, the first housing portion 230 may be configured as , to transport the enzyme vial 282 from the box 208 to the working space. The second set of connectors may define a recess 237 configured to receive the connector 282. The components 241 include a vial 243 containing a buffer, a needle 244, and a buffer syringe. The needle 244 may include a buffer syringe 245. The needle 244 is configured to be coupled to the buffer syringe 245. The needles 244 may be, for example, blunt filling needles. The components 261 include a vial 263 containing a buffer, a cell strainer 264, a set of skins A skin cell syringe 265, a set of needles 266, an unfiltered suspension syringe 267, a set of spray nozzles 2 68, and a pair of scalpels 269. The buffer vial 263 may be, for example, up to 30 ml. or other suitable volume of buffer. The buffer may be used to dilute or neutralize the enzyme. For example, in some embodiments, The buffer should be physiological saline (e.g., lactated Ringer's solution, sodium lactate solution, or Hart's solution). For example, a set of skin cell syringes 265 may contain four skin cell syringes. The set of syringes may include a suitable number of syringes, such as a set of 10 ml syringes. The needles 266 are arranged in a four needle (e.g., two by two stack in the third housing portion 260). A set of spray nozzles 2 may include any suitable number of needles, such as a blunt fill needle (not shown). 68 may include any suitable number of spray nozzles, such as four spray nozzles. Each of the six needles may be coupled to one of a set of skin cell syringes 265. As an alternative to each needle of the set of needles 266, each spray nozzle of the set of spray nozzles 268 may be a set of The first set of components may be coupled to one of the skin cell syringes 265. a second set of components 231, a second set of components 241, and a third set of components 26 Each of the components in kit 100 of FIG. corresponding components of the second set of components and the third set of components The components may be identical or similar in structure and / or function.
[0059] FIG. 3 illustrates a housing for a kit for preparing a cell suspension as described herein. The present invention relates to a device packaged in a housing, such as a device packaged in a ring, for use in thin film laser scanning. 3 is a flow chart illustrating a method 300 for preparing a cell suspension. Any of the kits described herein, such as kit 100 and / or kit 200. Good too.
[0060] The method 300 includes: a first label disposed adjacent to a first container of the device and a first housing; and identifying a first match with a first visual indicator included in the first housing portion. In response to (or after) identifying the first match, the first housing portion A first set of components is taken from the A first portion of a tissue processing method associated with one of the containers may be performed (30 4). Also, a second label and a second label of the housing are disposed adjacent to the second container of the device. and identifying a second match with a second visual indicator included in the housing portion. In response to (or after) identifying the second match, a second housing may be and removing a second set of components from the section, and using the second set of components, A second portion of the tissue processing method associated with the second container may be performed (30 8).
[0061] In this method, one or more housing parts are adapted to be moved to a sterile surgical area. In some embodiments, in response to identifying a first match (or After the first housing part is inserted into the surgical area, the second housing part may be moved to a sterile surgical area. In some embodiments, in response to (or after) identifying the second match, The second housing portion may be adapted to be moved to a sterile surgical area. In an embodiment, a third label is disposed adjacent to the third container of the device and the housing. and a third visual indicator included in the third housing portion. A third label disposed adjacent to the third container of the device and a third label on the housing may be disposed adjacent to the third container of the device. in response to identifying a third match with a third visual indicator included in the housing portion of the Removing a third set of components from the third housing portion and and performing a third portion of the tissue processing method associated with the third container using the component. In some embodiments, as described above, the preparation tray of the device may be In some embodiments, the tissue manipulation portion of the tissue processing method may be performed. The first set of components includes a vial of sterile water, a syringe, and an enzyme vial. It's okay to do that.
[0062] A first portion of the tissue processing method associated with the first container comprises preparing an enzyme mixture. and delivering the enzyme mixture to the first container. In the embodiment, the enzyme vial is taken out of the sterile pouch and placed in the first housing portion. In some embodiments, the enzyme vial may be disposed in the recess. The second set of components may include a buffer vial and a syringe. A second portion of the tissue processing method associated with the vessel includes dispensing a volume of buffer into a buffer bath. Draw a volume of buffer from the vial into a syringe and deliver a volume of buffer from the syringe to a second container. In some embodiments, the third set of components may include: The third component includes a syringe. A third portion of the tissue processing method associated with the third container includes a skin Disintegrating a skin sample and generating a cell suspension containing cells from the disintegrated skin sample. and drawing the cell suspension into a syringe.
[0063] Exemplary embodiments 4-6 are a perspective view, a top view, and a bottom view, respectively, of the kit 400. 400 may be configured as any of the kits described herein, such as kit 100 or kit 200. The structure and / or function may be the same or similar. The kit 400 includes a housing 120 and The housing may be structurally and / or functionally any of the housings described herein, such as housing 220. 4, includes a housing 420, which may be the same or similar. 420 includes a base 470 and a lid 472 coupled to the base 470. The inside of the base 470 is kept sterile until the kit 400 is used. The lid 472 may be secured to the housing 470 by, for example, one or more fasteners (e.g., adhesive, mechanical 3, the base 470 may be secured to the base 470 by means of a fastener, a snap fit, and / or the like. In some embodiments, the cover may include a removable cover. The lid 472 may be made of a polymer, foil, or the like (e.g., bonded to the base 470 by an adhesive). The lid 472 may include a cover such as a membrane that includes a transparent or semi-transparent For example, the lid 472 may be Alternatively, in some embodiments, the material may include Tyvek®. The lid 472 may include a hinged cover (e.g., similar to clamshell packaging). It's okay to be.
[0064] 7 and 8 are perspective views of the housing 420 with the lid 472 removed from the base 470. As shown in FIG. 7 and FIG. 8, the base 470 has a lid 452. A third housing portion 460 is provided having an integrated tray portion 450 and a lid 471. In some embodiments, the lid 452 and / or the lid 471 may be made of a material similar to that of the lid 472. FIG. 9 shows the first embodiment of the device with the lids 452 and 471 removed. The first housing portion 430, the second housing portion 440, and the third housing portion 460 are 9 is a top view of the exposed housing 420. As shown in FIG. The housing includes a first housing portion 430, a second housing portion 440, and a device 410. A part or the whole of the integrated tray portion 450 (for example, the first housing portion 43 0 and / or the second housing portion 440, by which the liner 436 is bonded to the , (e.g., in the first housing portion 430 and / or the second housing portion 440 and providing a cover (for holding the first and / or second set of components firmly together) In some embodiments, the first housing portion 430 and the second housing portion 430 may be The second housing portion 440 may be a separate and distinct liner (e.g., the first housing portion 430 and a second liner coupled to the second housing portion 440. Similarly, a liner 476 is coupled to the third housing portion 460. The third housing portion 460 holds a third set of components. The liner 436 and / or the liner 476 may provide a cover for the liner 436 and / or the liner 476. For example, the housing may have an outer periphery that matches the shape of one or more components in the housing. In some embodiments, the molded article may include one or more cavities or recesses. In this case, one or both liners are polyethylene terephthalate glycol (PET G) or other suitable materials.
[0065] FIG. 10 shows the liner 436 removed from the integrated tray portion 450 and the third housing portion. FIG. 4 is a perspective view of the housing 420 with the liner 476 removed from the housing 460. The first housing portion 430 and the second housing portion 440 are integrally formed with one another to form a one-piece In some embodiments, the first and the second housing portion are detachable from one another as described above (e.g., via perforations). As shown in FIG. 10, the first housing portion 430 may be 1 visual indicator 432 (e.g., the letter "A") and the second housing portion 4 40 includes a second visual indicator 442 (e.g., the letter "B") and a third housing Marking portion 460 includes a third visual indicator 462 (eg, the letter "C"). These visual indicators may be molded into the housing portion or may be decals. The markings may be applied to the surface as suitable markings such as marking marks (e.g., marking marks for markings on the back of the surface) or in any suitable manner. Further, these visual indicators may be located in the housing portion. may match or correspond to the label on the exterior of the device and may be The components located in may be associated with each portion of the tissue processing method.
[0066] The first housing portion 430 is configured to receive a first set of components 431. For example, the first set of components 431 includes one or more recesses formed therein. , a vial 433 containing a volume of water (e.g., sterile water), and a needle 434 (shown in FIG. 19 ). The first housing portion 430 holds a vial containing an enzyme, and an enzyme syringe 435. The vial recess 437 defines a vial configured to receive, for example, an enzyme syringe 435. The syringe 435 may be a 10 ml syringe. The needle 434 is adapted to be coupled to the enzyme syringe 435. However, the first set of components 431 is adapted for the tissue processing method. The recess may include any suitable component. For example, the recesses may be sized to suitable tolerances to hold components that can be moved with suitable forces. may be fixed and molded in place), and / or one or more fasteners (e.g. , elastics, straps, extensions, covers, etc.) and / or the like. 431 .
[0067] The second housing portion 440 is configured to receive a second set of components 441. The second set of components 441 includes one or more recesses formed therein. The vial 443 contains a needle 444, and a buffer syringe 445. The needle 444 is The needle 444 is configured to be coupled to a buffer syringe 445. The needle 444 may be, for example, a sharp However, the second set of components 441 may be a filling needle that is not a tissue processing method. The first housing portion 430 may include any suitable components suitable for the application. Similar to the recesses in the first housing portion 440, the recesses in the second housing portion 440 may be fitted with a snap fit, one or more The second set of components may be secured to the first set of components by a plurality of fasteners and / or the like. 441.
[0068] As shown in FIG. 10, a unified tray 450 (e.g., as described in more detail herein) is The device may further include a device recess configured to receive a device 410 (as will be described later). The device recess may be provided with a snap fit and / or one or more fasteners (e.g. (e.g. elastics, straps, extensions, covers, etc.) and / or similar The device may be sized and shaped to suitable tolerances to hold the device in place. .
[0069] The third housing portion 460 is configured to receive a third set of components 461. The third set of components 461 includes one or more recesses formed therein. a vial 463 containing such a buffer, a cell strainer 464, a set of skin cell syringes 465, A set of needles 466, an unfiltered suspension syringe 467, a set of spray nozzles 468, and a pair of The buffer vial 463 contains, for example, 30 ml of buffer. A set of skin cell syringes 465 may include four skin cell syringes (e.g., 10 ml The set of needles 466 may include any suitable number of syringes, such as four needles. (For example, 2×2 stacked non-pointed fillers in the third housing section 460 The set of spray nozzles 468 may include any suitable number of needles, such as four needles. Each needle in the set of needles 466 may include any suitable number of spray nozzles, such as a spray nozzle. may be coupled to one of a set of skin cell syringes 465. Also, a set of needles As an alternative to each needle of 466, each spray nozzle of a set of spray nozzles 468 sprays a set of skin cells. The third set of components may be coupled to one of the syringes 465. The container 461 may include any suitable components suitable for the tissue processing method. Similar to the recess in the first housing part 430, the recess in the third housing part 460 is adapted to be snap-fitted. The third, by means of a fit, one or more fasteners, and / or the like. The set of components 461 may be configured to receive the
[0070] The integrated tray portion 450 and the third housing portion 460 are removable from the base portion 470. For example, FIG. 11 shows the integrated tray portion 450 after it has been removed from the base portion 470. 1 is a perspective view of a device 410, a first housing containing a first set of components 431. and a second housing section 440 including a second set of components 441. 12 shows the integrated tray portion 450. 4 is a perspective view of a third housing portion 460 including a third set of components 461 after FIG. 13 shows a perspective view of base 470 separate from the other components of kit 400. As shown, the base portion 470 is configured to receive the integrated tray portion 450. The first recessed area 470a is configured to nestably receive the third housing portion 460. and a second recessed area 470b formed therein.
[0071] FIG. 17 illustrates a section including a base 470 that includes a third housing section 460 with a liner 476. FIG. 4 is a top view of the integrated tray portion 450 removed from the split housing and base 470. For example, the integrated tray portion 450 can be lifted off the base 470 and moved to a work area. This may aid in carrying out the first and second parts of the tissue processing method.
[0072] FIG. 18 illustrates a first housing portion 430, a second housing portion 440, and an apparatus 410. The partially disassembled housing includes an integrated tray portion 450 including the first housing portion 43. 0 and a top view of the liner 436 removed and separated from the second housing portion 440. FIG. 19 shows a first set of components 431 and a second set of components The tray 443 has been removed and is not shown, and the device 410 has been removed and separated from the integrated tray. 4 is a top view of part 450.
[0073] FIG. 23 illustrates a housing including a base 470, a third housing portion 460 and its liner 476. FIG. 4 is a top view of a partially exploded housing removed and separated from base 470. The third housing portion 460 can be lifted off the base portion 470 and moved to a work area. 24 shows the liner 476 being removed and used to aid in carrying out the third part of the tissue processing method. 4 is a top view of the third housing portion 460. FIG.
[0074] FIG. 14 is a top view of the device 410 with the cover portion removed. As shown, the device 4 10 includes a preparation tray 417 disposed in a recessed area 458 of the apparatus 410 . The apparatus 410 also includes a first container 411, a second container 413, and a third container 415. The device 410 also includes a first label 412, a second label 414, and a third label 415. 416 (e.g., colored labeled rings placed around the container) The first label 412 includes (e.g., a common color and / or the letter "A") 432) and the second label 41 4 is a second visual (e.g., by including a common color and / or the letter "B") The third label 416 may correspond to a third visual indicator 442. The enzyme vial 462 may correspond to the enzyme vial 462 (e.g., the letter "C"). FIG. 4 is a perspective view of an exemplary embodiment of 482. 411 may be configured to receive an enzyme vial 482. In an embodiment, the first container 411 receives the contents of the enzyme vial 482 via a syringe. The device may be configured to accommodate the above-mentioned.
[0075] The preparation tray 417 may be surrounded by a side wall at its bottom. The preparation tray 417 may comprise a tissue manipulation area. The collection area 409 may include one or more collection areas, such as two collection areas on either side of the collection area 409. Area 409 is a collection area where fluid poured into preparation tray 417 flows into and through the collection area 409. and / or a concave surface relative to the remainder of the bottom surface of the preparation tray 417 so that FIG. 15 shows the apparatus with the preparation tray 417 removed from the recessed area 458. 410. Other exemplary features of the preparation tray 417 are described in more detail below. Explain in detail.
[0076] FIG. 20 is a diagram of a portion of a device 410. As shown, a first label 412 is A first label 414 surrounds a second container 413 and a third label 416 surrounds the first container 411. surrounds a third container 415. The device 410 is as described above with respect to the kit 100 of FIG. 4, and various buttons, such as button 419 that can be pressed to activate the heating assembly. The device 410 may also include a set of one or more heating assemblies. The heating assembly may include one or more indicators 418. 8 corresponds to the indicator light of the device 410 as described above with respect to the kit 100 of FIG. The association may provide one or more statuses of the device (e.g., the heating status of the device 410). and an indicator configured to indicate one or more statuses of the assembly. FIG. 21 illustrates how the portion of device 410 shown in FIG. 20 may be used to manipulate tissue. 4A and 4B are shown on the apparatus 410 (adjacent to the preparation tray).
[0077] FIG. 22 illustrates the enzyme syringe 435 and the first container 411 of the first set of components 430. and the intended relationship between the buffer syringe 445 of the second set of components 440 and the first FIG. 4 is a perspective view of the device 410 with a portion enlarged to show its intended relationship to the second container 413. be.
[0078] Any of the devices described herein (e.g., device 110, device 210, and device 4) 10) The preparation tray is adapted to receive fluid from the preparation tray (e.g., via a syringe needle). The bottom surface may be of any suitable shape and contour so that collection may be effective. For example, Figures 25 and 26 are perspective and cross-sectional views, respectively, of preparation tray 517. The preparation tray 517 has a bottom surface 553 surrounded by a side wall 554. The major surface 557 includes a first lower surface 555A, and a second lower surface 555B. It may be or may include a skin tissue manipulation area. The bottom surface 553 has a first lower surface 555A that tapers downward from the major surface 557. The bottom surface 553 also includes a transition surface 556A from the major surface 557 to a second lower surface 555B. 26, the first and second transition surfaces 556A and 556B include a second transition surface 556B that is tapered downward. The second transition surface is shown as having a linear slope, although in some implementations In form, the transition may be curved (e.g., convex, concave, etc.) or any It is to be understood that the shape may be any suitable shape. In this embodiment, the transition surfaces 556A and 556B are adapted to contact each corner or edge of the preparation tray 517. (e.g., lower surfaces 555A and 555B may be omitted). The first lower surface 555A and / or the first transition surface 556A together form a first collection area. The second lower surface 555B and / or the second transition surface 556B integrally define a second By defining the collection area, the first collection area and the second collection area are formed from the main surface 557. The first collection area may be configured to allow fluid to flow to one or both of the collection areas. The first and second collection areas may be disposed at opposite ends of the preparation tray 517. (For example, to help facilitate easy tissue collection for both left- and right-handed users. In some embodiments, the preparation tray may additionally or alternatively include a 26, and a transition surface and a lower surface similar to those shown in FIG. 26 are used to The preparation tray 517 may include a collection area in the preparation area and / or the rear area. Although shown as having a qualitative semicircular or semimoon shape, any suitable shape (e.g. For example, it may be oval, rectangular, or circular.
[0079] 27 and 28 are perspective and cross-sectional views, respectively, of the preparation tray 617. The tray 617 has a bottom surface 653 surrounded by a side wall 654. 57, a lower surface 655A, and a tapered downward slope from the main surface 657 to the first lower surface 655A. 28, the transition surface 656A is generally linear. However, in some embodiments, this transition may be curved (e.g., convex, concave, etc.) or have any suitable shape. It is to be understood that in some embodiments, the transition surface 65 6A may extend to a corner or edge of the preparation tray 617 (e.g., lower surface 6 55A may be omitted). The main surface 657 may be a skin tissue manipulation area, The lower surface 655A and / or the transition surface 656A may include a skin tissue manipulation area. The surfaces 657 together define a collection area, thereby allowing fluid to flow from the main surface 657 to the collection area. In FIG. 27 and FIG. 28, the lower surface 655A is a prepared Although shown as being located on the left side of the tray, in some embodiments, It is understood that a similar lower surface 655A may be mirrored and located on the right side of the manufacturing tray. Additionally, in some embodiments, the preparation tray 617 may include additional or Alternatively, the study may be performed using transition and lower surfaces similar to those shown in Figures 27 and 28. The preparation tray may include a collection area in the front and / or rear region. Although the 617 is shown as having a substantially semicircular or semimoon shape, any It may be of any suitable shape (eg, oval, rectangular, circular).
[0080] 29 and 30 are perspective and cross-sectional views, respectively, of the preparation tray 717. Tray 717 is similar to that described above with respect to Figures 25 and 26, except that major surface 557 is omitted. The preparation tray 717 may be similar to the preparation tray 517. The preparation tray 717 may have a bottom surface 753 with a perimeter of a sidewall 754. The bottom surface 753 is surrounded by a first lower surface 755A and a second lower surface 755. B. The bottom surface 753 also includes a first lower surface 755A extending from the center line of the preparation tray. The bottom surface 753 includes a first transition surface 756A that tapers downwardly. From the center line of the first transition surface 756 (for example, the upper edge of the first transition surface 756) toward the second lower surface 755B. The first transition surface 756B includes a second transition surface 756B that is tapered downward. 56A and / or the second transition surface 756B, the upper edge of which is aligned with the centerline of the preparation tray. each upper edge may be offset (e.g. , tilting, lateral displacement, etc.) to cause the first transition surface 756A or the second transition surface 756 B may be greater than the other transition surface. One or both transition surfaces may be curved (e.g., convex, concave, etc.) or may be any suitable It is to be understood that the shape of the slit may be any suitable shape. 7, one or both transition surfaces extend to a corner or edge of the preparation tray 717. (e.g., lower surfaces 755A and / or 755B may be omitted). The first transition surface 756A and the second transition surface 756B are each a skin tissue manipulation area. The first lower surface 755A and / or the skin tissue manipulation area may be included. or first transition surface 756A together define a first collection area, and second lower surface 755B and / or the second transition surface 756B together defines a second collection area. so that fluid can flow to one or both of the first and second collection areas. The first collection area and the second collection area may be Further, in some embodiments, the preparation tray may be provided with a In addition or alternatively, transition and lower surfaces similar to those shown in Figs. 29 and 30 may be used. 7, including a collection area in the front and / or rear region of the preparation tray 717. The preparation tray 717 may have a substantially semicircular or semimoon shape. However, the shape may be any suitable shape (e.g., oval, rectangular, circular). stomach.
[0081] 25 to 30 show a configuration in which at least one collection area is provided on a side portion (e.g., left side, right side). Although an exemplary embodiment of a preparation tray having A manufacturing tray may have one or more collection areas located in other areas of the tray. For example, Figures 31 and 32 are perspective and cross-sectional views, respectively, of preparation tray 817. FIG. 1 shows a preparation tray 817 having a collection The preparation tray 817 includes a bottom surface 853 and a side wall 854 around the periphery of the bottom surface 853. Surface 853 is tapered from the first end of preparation tray 817 toward the center of preparation tray 817. A first transition surface 856A is inclined downwardly in a bell-like shape, and a second end of the preparation tray 817 is connected to the preparation tray. tapered toward the center of ray 817 (e.g., the lower edge of first transition surface 856A) and a downwardly sloping second transition surface 856B. Alternatively, the first transition surface 856A and and / or the second transition surface 856B may have a lower edge that is not aligned with the centerline of the preparation tray. Often, each lower edge is offset (e.g., sloped, lateral) from the centerline of the preparation tray. By changing the position of the first transition surface 856A or the second transition surface 856B, the first transition surface 856A or the second transition surface 856B becomes closer to the other transition surface 856A. In some embodiments, one or both of the transition surfaces may be larger than the transition surface. Either transition surface may be curved (e.g., convex, concave, etc.) or have any suitable shape. It is to be understood that the first transition surface 856A and the second transition surface Each of 856B may be a skin tissue manipulation area or may include a skin tissue manipulation area. The first transition surface 856A and the second transition surface 856B may together form a collection area. 8, the first transition surface 856A is aligned with the second transition surface 756B. Further, in some embodiments, The preparation tray may additionally or alternatively include transition surfaces and and a lower surface to provide a collection area at the front and / or rear area of the preparation tray 817. The preparation tray 717 may have a substantially semicircular or semimoon shape. However, the shape may be any suitable shape (e.g., oval, rectangular, circular). It is also possible.
[0082] 33 and 34 are perspective and cross-sectional views, respectively, of the preparation tray 917. The tray 917 has a bottom surface 953 surrounded by a side wall 954. 57, lower surface 955B, and transition surface 956B. The transition surface 956A may be a major surface or may include a skin tissue manipulation area. 957 tapers downwardly to a lower surface 955A. As shown in FIG. Surface 956B is shown as having a generally linear slope. In embodiments, the transition may be curved (e.g., convex, concave, etc.) or may be any It is to be understood that the lower surface 955A and the transition surface 955B may have any suitable shape. The transition surface 956A together defines a collection area, which allows the first collection surface 956A to pass from the main surface 957 to the first collection surface 956B. The collection area may be configured to allow fluid to flow into the preparation tray 917. The preparation tray shown in Figures 33 and 34 may be disposed at the ends and / or corners. The collection area is to the right of the preparation tray 917, but in some embodiments, It may be present on the left side (or front or back, etc.) of the preparation tray as well. Although the 917 is shown as having a substantially semicircular or semimoon shape, any It may be of any suitable shape (eg, oval, rectangular, circular).
[0083] 35 and 36 are perspective and cross-sectional views, respectively, of the preparation tray 1017. The bottom surface 1053 of the tray 1017 is surrounded by a side wall 1054. The lower surface 1055A is connected to a first end of the bottom surface 1053 of the preparation tray 1017 from a second end of the preparation tray 1017. a transition surface 1056 that tapers downward to a first lower surface 1055A disposed at the end of the As shown in FIG. 36, the transition surface 1056A has a generally linear slope. However, in some embodiments, the transition may be curved (e.g., It will be appreciated that the shape may be any suitable shape (e.g., convex, concave, etc.) The transition surface 1056A may be a skin tissue manipulation area or a skin tissue manipulation area. The lower surface 1055A and / or the transition surface 1056A may include a weaving operation area. By integrally defining a collection area, fluid can flow toward the collection area. The collection area of the preparation tray 1017 shown in FIG. on the left side of the tray, but in some embodiments on the left side (or front) of the preparation tray. The preparation tray 1017 may be substantially semicircular. Although shown as having an egg-shaped or crescent shape, any suitable shape (e.g., The shape may be rectangular, circular, etc.
[0084] Additionally or alternatively, in some embodiments, the preparation tray comprises at least one The skin sample may include at least one textured surface. The technology is designed to facilitate mechanical disintegration by rubbing, pressing, or exerting force against a surface. A textured surface may be located in the skin tissue manipulation area of the preparation tray. In an embodiment, at least one textured surface includes one or more raised features. For example, the one or more raised features may be between about 0.05 mm and about 2mm, 0.05mm~1.5mm, 0.05mm~1mm, Approximately 0.1mm to approximately 2mm, approximately 0.1mm to approximately 1.5mm, or approximately In some embodiments, the at least one of the at least two ... At least one textured surface may additionally or alternatively include one or more concave features. For example, the one or more concave features may include a Approximately 2mm, approximately 0.05mm to approximately 1.5mm, approximately 0.05mm to approximately 1m m, about 0.1 mm to about 2 mm, about 0.1 mm to about 1.5 mm, or In some embodiments, the depth is about 0.1 mm to about 1 mm. , the one or more raised features and / or the one or more recessed features are approximately 0.05mm to approx. 1mm, approx. 0.05mm to approx. 0.5mm, or approx. 0 It may have a width or depth of .5mm to approximately 1mm.
[0085] For example, as shown in FIG. 37, the skin tissue manipulation area 1151 is arranged in a two-dimensional array. The raised features may include a set of one or more raised texture features. at least one of the following is cylindrical (e.g., circular cross section, other polygonal cross section); and and / or at least one of the raised features is tapered (e.g., pyramidal, domed, etc. It is contemplated that the spheroid may have any suitable shape (e.g., round, round, etc.) or any suitable configuration. For example, some In an embodiment, some or all of the raised features are tapered to have an uppermost point. Such tapered features may, in some aspects, have a height similar to that described above. and / or width. The set of raised features may be rectangular shaped as shown in FIG. Any suitable array may be used, such as a ray, a triangular array, a hexagonal array, an irregular or random array, etc. Similarly, in some embodiments, the preparation tray may be 37, and / or any other suitable rectangular arrays similar to those shown in FIG. The substrate may include a set of concave features (e.g., depressions) arranged in a suitable array. 7 shows, for illustrative purposes, a two collection area similar to that described above with respect to FIGS. Although the textured surface on the preparation tray having 25-36) also have a raised portion similar to that described above with respect to FIG. It may include at least one textured surface having features and / or depressions. This is understood.
[0086] As another example of a preparation tray having a textured surface, FIG. A preparation technique including a skin manipulation area 1251 including one or more raised texture features. 38 is a perspective view of a ray 1217. For example, as shown in FIG. Contains one or more elongated ridges (e.g., parallel ridges) In some embodiments, the one or more elongated ridges may be generally prismatic (e.g. It may be rectangular (e.g., rectangular prism) or angled (e.g., angled fins). The elongated ridge may be dome-shaped (e.g., have a curved cross-sectional profile). The electrodes may be arranged parallel to one another or in any suitable manner (e.g., angled or The orientation of the matrix may be non-parallel, random, etc. Similarly, in some embodiments, the preparation The ray may additionally or alternatively be in a manner similar to that shown in FIG. 38 and / or in any suitable manner. The substrate may include a set of recessed features (e.g., trenches) arranged in a suitable array. 38 shows, for illustrative purposes, two similar lattices as those described above with respect to FIGS. The textured surface on the preparation tray with collection area is shown, but any preparation tray (e.g. For example, the preparation tray described above with respect to Figs. 25-36 may be similar to that described above with respect to Fig. 38. at least one textured surface having raised features and / or recesses similar to It is understood that
[0087] The transition surface of the preparation trays described herein directs the flow of cells to one or more of the preparation trays. It may have any suitable taper or angle to guide it towards a suitable collection area. In some embodiments, the incline or slope of the preparation tray is approximately 0.5 35°, 0.5° to 25°, 0.5° to 15°, Approximately 5° to approximately 35°, approximately 5° to approximately 25°, approximately 5° to approximately 15°, and It may be between about 15° and about 35°, or between about 15° and about 25°. In this embodiment, the preferred gradient may be determined, for example, by the material properties (e.g., hydrophobicity) and / or or the surface coating of the preparation tray. For example, highly hydrophobic materials and and / or a surface coating to direct the flow of cells toward the collection area. For example, FIG. 39 shows a cross-section of a preparation tray 1317. The preparation tray 1317 can be used to hold any of the preparation trays described herein, such as the preparation tray 517. The tray may be identical or similar in structure and / or function to any of the trays. For example, The preparation tray 1317 has a major surface 1357 and a lower surface 1355B. and a transition surface 1356B that tapers to major surface 1355B. 357 to the lower surface 1355B, which tapers at an angle of 4° to the main surface 1357. There are.
[0088] FIG. 40 is a partial cross-sectional view of the preparation tray 1417. Same structure and / or function as any of the preparation trays described herein, such as the Ray 517. For example, the preparation tray 1417 may have a major surface 1457 and a lower surface 1458. 1455B, a transition surface 1456B tapered from the major surface 1457 to the lower surface 1455B, The transition surface 1456B extends from the major surface 1457 to the lower surface 1455B. It tapers at an angle of 4°.
[0089] FIG. 41 is a partial cross-sectional view of the preparation tray 1517. Same structure and / or function as any of the preparation trays described herein, such as the Ray 517. For example, the preparation tray 1517 may have a major surface 1557, a lower surface 1558, and the like. 555B, a first transition surface 1556B, and a second transition surface 1556C. Surface 1556B tapers at a first angle from major surface 1557 to a second transition surface 1556C. The second transition surface 1556C may be a distance from the first transition surface 1556B to the bottom surface 1556C. 55B. The first transition surface 1556B may taper at a second angle to the first transition surface 1556B. The surface 1557 tapers at an angle of 4° to the second transition surface 1556C. The second transition surface 1556C is a transition surface from the first transition surface 1556B to the lower surface 1556C. Up to 5B, it tapers at an angle of 7° to the main surface 1557.
[0090] FIG. 59 is a top view of an apparatus 2010 for producing a cell suspension. Same or similar in structure and / or function to any of the devices described herein. For example, the apparatus 2010 includes a preparation tray 2017. The preparation tray 201 has a bottom surface 2053 surrounded by a side wall 2054. 7, a recess or cavity 2099 (e.g., a circular collection area) disposed at a corner of the By including, (for example, when the opposite end of the preparation tray 2017 is lifted 2) The fluid may be allowed to collect in the recess or cavity 2099. Once stored in the depression or cavity 2099, the material may be injected, for example, using a syringe, as described in detail above. Bulk retrieval of fluids using a pump or other pumps can be more efficient. In an embodiment, any of the preparation trays described above may have a similar recess or cavity in the collection area. It may also include tea.
[0091] 42 is a perspective view of an exemplary embodiment of a kit 1600. The kit 1600 includes: The same or similar in structure and / or function to any of the kits described herein For example, the kit 1600 may include a first housing portion 1630, a second housing portion 1631, and a The housing 1620 includes a first housing portion 1640, and a third housing portion 1660. The first housing portion 1630 can be adapted to perform a tissue processing method, such as any of the tissue processing methods described herein. configured to receive a first set of components 1631 associated with a first portion of the The second housing portion 1640 includes a recess formed therein. a recess configured to receive a second set of components 1641 attached to the The third housing portion 1660 includes a third part associated with a third part of the tissue processing method. The first housing includes a recess configured to receive the pair of components 1661. The unit 1630 includes a first visual indicator 1632 associated with a first label of the device. The device may be identical in structure and / or function to any of the devices described herein. The second housing portion 1640 may be associated with a second label of the device. The third housing portion 1660 includes a second visual indicator 1642. and a third visual indicator 1662 associated with the third label.
[0092] As shown in FIG. 42, a first housing portion 1630, a second housing portion 1640, and and the third housing portion 1660 are integrally formed with one another to form a unitary structure (e.g., As shown in FIG. 42, the first visual indicator 163 2 includes the letter "A," a second visual indicator 1642 includes the letter "B," and a third Visual indicator 1662 includes the letter "C." Additionally or alternatively, other types of visual indicators may be used. The housing may include visual indicators (e.g., letters, symbols, punctuation marks, textures, etc.). For example, a portion of the housing 1620 may be transparent, and the first The visual indicator 1632 is a blue background visible through the top of the housing 1620. The second visual indicator 1642 may include a background image on the top of the housing 1620. The third visual indicator 166 may include a gray background that is visible through the 2 may include a green background visible through the top of the housing. As shown in FIG. 2, a first set of components 1631, a second set of components 1 641, and a third set of components 1661, One or more of the recesses or cavities configured to Guide users to use items in the intended order (e.g., pick and implement) For ease of understanding, the reference numbers may be the same as those for specific steps in the tissue processing method.
[0093] As shown in FIG. 42, a first set of components 1631 includes a volume of water (e.g., A vial 1633 containing a sample (e.g., sterile water), a needle 1634, an enzyme syringe 1635, and a cell filter. For example, the enzyme syringe 1635 may be a 10 ml syringe. The needle 1634 is configured to be coupled to an enzyme syringe 1635. The set of components 1631 may optionally include an enzyme vial 1682 similar to that described above. Includes.
[0094] The second set of components 1641 includes a vial 1643 containing a buffer, a needle 164 4, a buffer syringe 1645, and an unfiltered suspension syringe 1667. The needle 1644 , and is configured to be coupled to a buffer syringe 1645. The needle 1644 may be, for example, The second set of components 1641 may be a blunt filling needle. A second set of components 1641 also includes a pair of females 1669, similar to those described above. A vial 1663 containing a buffer may be included. For example, it may contain 30 ml of buffer.
[0095] The third set of components 1661 includes a set of skin cell syringes 1665, a set of needles 1666, and a set of skin cell syringes 1667. 666, and a set of spray nozzles 1668. The set of skin cell syringes 1665 includes four Any suitable number of skin cell injections, such as one skin cell syringe (e.g., a 10 ml syringe) The set of needles 1666 may include four needles (e.g., a third housing part 1660) or any suitable number of needles. The set of spray nozzles 1668 may include any suitable number of spray nozzles, such as four spray nozzles. Each needle in the set of needles 1666 may include a set of skin cell injectors. 1665. Alternatively, each needle of the set of needles 1666 may be attached to one of the needles. Each spray nozzle of the set of spray nozzles 1668 is connected to a set of skin cell syringes 1665. It may be bonded to one of them.
[0096] 43 is a perspective view of an exemplary embodiment of a kit 1700. The kit 1700 includes: The same or similar in structure and / or function to any of the kits described herein For example, the kit 1700 may include a first housing portion 1730, a second housing portion 1731, and a The housing 1720 includes a first housing portion 1740, and a third housing portion 1760. The first housing portion 1730 may be adapted for use in a tissue processing method, such as any of the tissue processing methods described herein. configured to receive a first set of components 1731 associated with a first portion of the The second housing portion 1740 includes a recess formed therein. a recess configured to receive a second set of components 1741 attached to the The third housing portion 1760 includes a third part associated with a third part of the tissue processing method. The first housing includes a recess configured to receive the pair of components 1761. Section 1730 includes a first visual indicator 1732 associated with a first label of the device. The device may be identical in structure and / or function to any of the devices described herein. The second housing portion 1740 may be associated with a second label of the device. The third housing portion 1760 includes a second visual indicator 1742. and a third visual indicator 1762 associated with the third label.
[0097] As shown in FIG. 43, a first housing portion 1730, a second housing portion 1740, and and third housing portion 1760 are integrally formed with one another to form a unitary structure (e.g., As shown in FIG. 43, the first visual indicator 173 2 is a first component at least partially surrounding each component of the first set of components. A second visual indicator 1742 may include a color label (e.g., blue). a second color at least partially surrounding each component of the second set of components; A third visual indicator 1762 may include a label (e.g., gray) for , a third color at least partially surrounding each component of the first set of components. A first set of labels (e.g., green) may also be included, as shown in FIG. a first set of components 1631, a second set of components 1641, and a third set of The components 1661 each include a recess or recesses configured to receive each of the components. or one or more of the cavities may be inserted in the order intended by the user. The specifics of the tissue processing method so that the tissue is induced to be used (e.g., removed and mounted) The steps may be identified by reference numbers for certain steps.
[0098] As shown in FIG. 43, a first set of components 1731 includes a volume of water (e.g., A vial 1733 containing a sample (e.g., sterile water), a needle 1734, an enzyme syringe 1735, and a cell filter. For example, the enzyme syringe 1735 may be a 10 ml syringe. The needle 1734 is configured to be coupled to an enzyme syringe 1735. The set of components 1731 optionally includes an enzyme vial 1782 .
[0099] The second set of components 1741 includes a vial 1743 containing a buffer, a needle 174 4, buffer syringe 1745, and unfiltered suspension syringe 1767. Needle 1744 is , and a buffer syringe 1745. The needle 1744 may be, for example, The second set of components 1741 may be a blunt filling needle. The second set of components 1741 also includes a pair of female connectors 1769. The buffer vial 1763 may contain, for example, 30 ml of It may contain a buffer of l.
[0100] The third set of components 1761 includes a set of skin cell syringes 1765, a set of needles 1766, and a set of skin cell syringes 1767. 766, and a set of spray nozzles 1768. The set of skin cell syringes 1765 includes four Any suitable number of skin cell injections, such as one skin cell syringe (e.g., a 10 ml syringe) The set of needles 1766 may include four needles (e.g., a third housing part 1760) or any suitable number of needles. The set of spray nozzles 1768 may include any suitable number of spray nozzles, such as four spray nozzles. Each needle in the set of needles 1766 may include a set of skin cell injectors. 1765. Alternatively, each needle of the set of needles 1766 may be coupled to one of the needles 1765. Each spray nozzle of the set of spray nozzles 1768 is connected to a set of skin cell syringes 1765. It may be bonded to one of them.
[0101] 44 is a perspective view of an exemplary embodiment of a kit 1800. The kit 1800 includes: The same or similar in structure and / or function to any of the kits described herein For example, the kit 1800 may include a first housing portion 1830, a second housing portion 1831, and a The housing 1820 includes a first housing portion 1840, and a third housing portion 1860. The first housing portion 1830 can be adapted to perform a tissue processing method, such as any of the tissue processing methods described herein. configured to receive a first set of components 1831 associated with a first portion of the The second housing portion 1840 includes a recess formed therein. a recess configured to receive a second set of components 1841 attached to the The third housing portion 1860 includes a third part associated with a third part of the tissue processing method. The set includes a recess configured to receive a component 1861 .
[0102] The kit 1800 may be identical in structure and / or function to any of the devices described herein. or a similar device 1810. The kit 1800 includes a first housing portion 18 30, a second housing portion 1840, and a first housing portion configured to receive the device 1810. The first housing portion 1830 and the second housing portion 1840 are disposed in a housing unit 1850. 1840 is a one-piece tray configured to be lifted from the one-piece tray 1850 It is formed as a structure.
[0103] The kit 1800 also includes a base 1870 and a box 1880. 70 is configured to receive a unified tray 1850 and a third housing portion 1860. Box 1808 has a base 1870 at a first portion of the box 1808. The enzyme vial recess 188 in the second portion of the box 1808 is configured to receive The box 1808 is configured to receive an enzyme vial 1882 at the Enzyme vial 1882 or enzyme vial 188 in the second portion of box 1808 Regardless of the sterility of the pouch containing the 2, the base of the first portion of the box 1808 The second portion of the box 1808 is then filled with 1870 so as to maintain the sterility of the contents of the box 1808. a partition 1859 disposed to separate a first portion of the box 1808 from the It is okay to do so.
[0104] In some embodiments, the base 1870 has a seal that breaks when the pull tab is pulled; A removable seal on the base 1870 to allow access to the interior of the base 1870 The packaging material may be formed as an integral protective packaging layer including a pull tab coupled thereto. Also, the base portion 1870, the integrated tray portion 1850, the first housing portion 1830, the second housing portion 1830, The first housing portion 1840 and the second housing portion 1860 are each It may be transparent to allow a user to view the components disposed therein.
[0105] Method for packaging a kit 45-58 show a kit or Figures 45 to 58 show the steps of packaging a set of kits. Although several embodiments are shown, the present invention is not limited to the above. In some embodiments, the method may include any suitable number (e.g., 1, 2, 4, 5, 6 or more) of It is understood that the present invention may be modified to package a kit of any of the above in a shipping container. The methods shown in Figures 45 to 58 are intended to be used for a predetermined period of time, such as up to about 48 hours. Therefore, the stable temperature of the kit can be adjusted to the desired temperature or temperature range (e.g., approximately 20°C to 40°C). This may include lamination of cold chain shipping materials to maintain the temperature at approximately 25°C. Maintaining a stable temperature of the kit within a certain desired temperature range can be achieved by, for example, or impair the viability or chemical state of several components (e.g., enzymes). This is considered important because
[0106] Generally, the method of packaging a kit (any of the kits described herein) includes In an insulated container, one or more kits are placed between the foam insert and the refrigerated brick material. The container may include, for example, stacking layers of insulating material. (e.g., insulating foam) and / or one or more It may be insulated by having an insulating liner or pad. Absorbent wipes may be placed within the layer of material to help absorb condensation etc.
[0107] For example, FIG. 45 shows an empty container 1990. The container 1990 may be, for example, The container 1990 may be made of any suitable material, such as cardboard, foam, etc. , insulation 1988 and liner 1989. As shown in FIG. 46, the first form An insert 1991 may be disposed in the container 1990. The 1991 Consert contains a set of refrigerated bricks 1992 (e.g., refrigerated FB24 bricks). For example, a set of five refrigeration bricks 1992 may be provided with a central opening through which the refrigeration bricks can be installed. It may also be disposed in the central opening.
[0108] As shown in FIG. 47, a set of absorbent wipes 1993 (e.g., two absorbent wipes) The cooling brick 1992 may be disposed on the cooling brick 1992.
[0109] As shown in FIG. 48, a second foam insert 1994 is inserted into the absorbent material of the container 1990. It may also be disposed on top of the wipe 1993 .
[0110] As shown in FIG. 49, the first kit 1902A is inserted into the second foam insert of the container 1990. Alternatively, the sensor may be disposed on the insert 1994.
[0111] As shown in FIG. 50, the second kit 1902B is inserted into the first kit 1902B of the container 1990. It may be arranged on top of 02A.
[0112] As shown in FIG. 51, the third kit 1902C is inserted into the second kit 1902A of the container 1990. Similarly, an additional kit may be placed on top of the third kit. It may be arranged so as to
[0113] As shown in FIG. 52, a third foam insert 1995 is inserted into the third compartment of the container 1990. It may be placed on top of kit 1902C.
[0114] As shown in FIG. 53, an absorbent wipe 1996 (e.g., two absorbent wipes) is placed on the second The foam insert 1995 may be placed on top of the foam insert 1995.
[0115] As shown in FIG. 54, a fourth foam insert 1997 is inserted into the absorbent material of the container 1990. The fourth foam insert 1997 may be disposed on top of the wipe 1996. , a central opening into which a set of refrigerated bricks 1998 (e.g., refrigerated FB24 bricks) can be placed. For example, a set of five refrigeration bricks 1998 may be arranged in a central opening. This may be done.
[0116] As shown in FIG. 55, place an insulating pad 1999 (e.g., insulating foam) into the container 19 90 may be disposed on top of the fourth foam insert 1997. 1999, for example, to create an enclosed space that captures thermal energy inside a container. In some embodiments, the insulating pad 1999 may be attached to the wall of the container. By fitting as closely as possible, the gap or It may be sized to reduce the heat energy that escapes through the space. Alternatively, the insulating pad may be an insulating foil wrapped (e.g., lined) with metal foil. The inclusion of a foam helps to retain the thermal energy inside the container for as long as possible. This can be useful for:
[0117] As shown in FIG. 56, the liner 1989 defines an enclosed interior space within the container 1990. The liner 1989 may be closed to secure the container in place. It acts to help bind components tightly enough to make the package The present invention may be modified to reduce undesirable relative axis wobble of the jigs. Alternatively, Liner 1989 has warned that the container may deteriorate and endanger the kit inside. Helps protect surrounding containers (e.g. cardboard boxes) from condensation that can cause For example, the liner 1989 may be made of a suitable waterproof or water-resistant material such as polyethylene. It may also include a waterproof layer (e.g., a sheet, bag, other cover). In some embodiments, condensation or other moisture may be present to protect the container (or other components that are sensitive to moisture). Multiple (e.g., two or more) liners are used to provide extra or redundant protection for the may be included in the container 1990.
[0118] As shown in FIG. 57, the flap 1987 of the container 1990 is closed and secured. Container 1990 may then be sealed (eg, with tape).
[0119] As shown in FIG. 58, the container 1990 is placed in the chamber along with other containers and A strike may also be carried out.
[0120] The various concepts can be implemented as one or more methods, at least one of which is An example has been provided. The actions performed as part of this method may be ordered in any suitable manner. Thus, although shown as sequential operations in the exemplary embodiment, Operations may be performed in an order different from that illustrated, including performing some operations simultaneously. In other words, such features are not necessarily required for a particular implementation. It is not limited to row order, but rather may be sequential, asynchronous, or any combination thereof in a manner consistent with this disclosure. , concurrently, in parallel, simultaneously, synchronously, and / or in any number of similar ways. There may be multiple threads, processes, services, servers, and / or the like. It is to be understood that several of the above-described features may be combined in a single embodiment. They may be mutually inconsistent in that they may not exist simultaneously in the same place. Some features may be applicable to one aspect of a technological innovation but not to another. It is.
[0121] The present disclosure may also include other technical innovations not described herein. Any person may have the right to implement such innovations, to file additional applications, continuation applications, continuation-in-part applications, divisional applications, All rights relating to such innovations, including applications and / or similar rights Therefore, the advantages, embodiments, examples, functions, features, logic, operation, system, The structure, topology, and / or other aspects of the present disclosure are defined by the embodiments. It is understood that the present invention should not be construed as a limitation on the scope of the present invention or on the equivalents of the embodiments. The specific needs and / or characteristics of individual and / or corporate users, data structures and / or relationship models, data types, data transmission and / or network Depending on the framework, syntactic structure, and / or the like, The techniques disclosed herein are implemented in a manner that allows for a great deal of flexibility and customization as described. Various embodiments of the present invention are possible.
[0122] All definitions used herein are taken from dictionary definitions, definitions in incorporated documents, and and / or ordinary meaning of the defined terms shall be understood to control.
[0123] As used herein, in certain embodiments, the term "approximately" before a numerical value "About" or "approximately" means a range of ±10% of the value in question. Where a range of values is given, the lower limit is used unless the context clearly indicates otherwise. Each value between the upper and lower limits of the range, to the tenth of a unit, and within the range It is understood that other defined or occurring values for these smaller ranges are included in the present disclosure. The upper and lower limits of a range may independently be included in the smaller range, and specific exclusions within the stated range are also included. Any limits excluded are included in the present disclosure. If both are included, the range excluding one or both of these included limits is also included in the scope of this disclosure. Included in the indication.
[0124] As used herein and in the embodiments, the indefinite articles "a" and "an" specifically refer to Insofar as the term "at least one" is expressly specified, it shall be understood to mean "at least one".
[0125] As used herein and in the embodiments, the phrase "and / or" refers to " refers to "either or both" of the elements so joined, i.e., in some cases, conjunctively It is to be understood that the term "conjunction" refers to elements which are conjunctively present in other cases and disjunctively present in other cases. Multiple elements listed with "and / or" are treated in the same manner, i.e. i.e., to be construed as "one or more" of the elements so combined. Optionally, any element specifically identified in the "and / or" clause. There may be other elements, whether related or not, other than those specifically identified. Thus, as a non-limiting example, "A and / or B" may be used. B)" refers to open-ended expressions such as "comprising" When used in combination with, in one embodiment, it represents only A (optionally including elements other than B). In another embodiment, it represents only B (optionally including elements other than A). In yet another embodiment, both A and B may be present (optionally , including other elements).
[0126] As used herein and in the embodiments, "or" means any combination of the terms "and" and "any combination" as defined above. "and / or" shall be understood to have the same meaning as "and / or." For example, you can use "or" or "and / or" to separate items in a list. nd / or) is inclusive, i.e., at least one of many elements or elements in a list Contains one, and two or more, and optionally includes an additional item not listed It is interpreted as "only one of" or "of" "exactly one of," or when used in an embodiment In the case of "consisting of" or other terms with a specific, clearly specified designation, Only thereby is it expressed that a list contains exactly one of the elements or list of elements. As used herein, the term "or" generally means "either "her", "one of", "only one of" "one of" or "exactly one of Exclusive alternatives (i.e., "either or the other") are permitted only if preceded by a term of exclusivity, such as " one or the other but not both h)"). When used in the embodiments, "essentially consists of "consisting essentially of" is used in the field of patent law. "Conditions" and "Conditions" shall have the ordinary meaning given to them.
[0127] As used herein and in the embodiments, a list of one or more elements may be referred to. The expression "at least one" means that one or more of a list of elements It is understood that "at least one element selected from any of a plurality of elements" means "at least one element selected from any of a plurality of elements." At least one of each and every element specifically listed in the list of elements must be present. This definition does not include or exclude any combination of elements in the list. If the expression "at least one" is used, Specifically identified, whether or not related to a specifically identified element in the list of elements There may be other elements present than the elements shown. Thus, as a non-limiting example, "A and at least one of A and B" (or etc.) Evaluatively, "at least one of A or B" "A and / or B" or equivalently "at least one of A and / or B" "ne of A and / or B") means, in one embodiment, that B is absent, or At least one A (optionally including two or more elements other than B) In another embodiment, A is absent, optionally, two or more represents at least one B (optionally including elements other than A), including the above, and In another embodiment, optionally, at least one A, including two or more, and Optionally, at least one B (and optionally other Bs) including two or more Bs elements), etc.
[0128] In addition to the embodiments, in the above specification, the words "comprising" and "including "including," "carrying," "having" "containing," "involving," "protecting" "holding", "composed of", etc. All transitional phrases are open-ended, i.e., "including, but not limited to..." "including but not limited to" The transitional phrases "consisting of" and "consisting essentially of" Only "onsisting essentially of" is a patent examination procedure of the U.S. Patent Office. Each may be closed or semi-closed, as defined in Section 2111.03 of the Supplementary Manual. It shall be a transitional phrase.
[0129] While specific embodiments of the present disclosure have been outlined above, many alternatives, modifications, and variations will become apparent to those of ordinary skill in the art. Various modifications and variations will become apparent to those skilled in the art. Accordingly, the embodiments described herein are intended to be illustrative and not restrictive. The present disclosure is not intended to be limiting in any way, and is not intended to depart from the spirit and scope of the present disclosure. It is understood that various modifications may be made without departing from the spirit and scope of the invention. Where an embodiment is shown, it will be understood that those skilled in the art having the benefit of this disclosure may vary the order of certain steps. and it will be recognized that such modifications are in accordance with the scope of the present invention. In addition to performing certain steps sequentially as described above, parallel processes may be performed simultaneously if possible. Although the embodiments have been shown and described in detail above, the form and details may be changed without departing from the spirit and scope of the present invention. It will be appreciated that many variations in details are possible.
Claims
1. A kit for preparing a cell suspension, comprising: An apparatus for use in a first portion of a tissue processing method, the apparatus defining a first container and a second container. a first label identifying the first container for use in a second portion of the tissue processing method; and a second label identifying the second container; a housing configured to receive the device; a first set of components associated with the first portion of the tissue processing method; a first visual indicator configured to store a first visual indicator associated with the first label of the device; a first housing portion including an indicator; a second set of components associated with the second portion of the tissue processing method; a second visual indicator configured to store a second visual indicator associated with the second label of the device; a second housing portion including an indicator; a housing including: A kit equipped with
2. The first housing portion is integrally attached to the second housing portion at an integral tray portion. The kit of claim 1 formed.
3. 3. The method of claim 2, wherein the integrated tray portion includes a recess configured to receive the device. The kit according to claim 1,
4. 2. The method of claim 1 , wherein the first housing portion is separate from the second housing portion. The kit described.
5. The first housing part is coupled to the second housing part via a slotted connection part. The kit of claim 1 .
6. The housing receives the first housing portion and the second housing portion. The kit of claim 1 , further comprising a base configured to:
7. The apparatus defines a third container and, prior to use in a third part of the tissue processing method, a third label identifying the third container, and the housing is configured to store a third set of components associated with the third portion; a third handheld device including a third visual indicator associated with the third label of the device; 2. The kit of claim 1, further comprising a housing.
8. The housing includes the first housing portion, the second housing portion, and the 8. The kit of claim 7, further comprising a base configured to receive the three housing parts.
9. The first set of components comprises an enzyme vial, and the first housing portion 2. The kit of claim 1, comprising a recess configured to receive the enzyme vial.
10. the first visual indicator and the first label each include a first color; The second visual indicator and the second label each include a second color. the third visual indicator and the third label each include a third color. Item 2. The system described in item 1.
11. The first visual indicator and the first label each include a first character. the second visual indicator and the second label each include a second character. , the third visual indicator and the third label each include a third character. The system of claim 1 .
12. The second part of the tissue processing method is sequentially performed after the first part of the tissue processing method. The system of claim 1 .
13. The device includes a skin tissue manipulation area surrounded by a sidewall and including a textured surface region. The system of claim 1 , comprising:
14. 10. The system of claim 1, wherein the first set of components includes a vial containing an enzyme. Stem.
15. 10. The method of claim 1, wherein the second set of components comprises a vial containing a buffer. system.
16. A packaging system for an apparatus for preparing a cell suspension, the apparatus comprising: The package defines a first container having a first label and a second container having a second label.
1. A caging system comprising: The tissue processing method includes: a first label associated with the device, the first label defining a set of recesses configured as follows: a first housing portion including a visual indicator of a second set of components associated with a second portion of the tissue processing method; a pair of recesses configured to receive the second label of the device; a second housing portion including a second visual indicator; A packaging system comprising:
17. The first housing portion is integrally attached to the second housing portion at an integral tray portion.
20. The packaging system of claim 16 formed.
18. 2. The method of claim 1, wherein the integrated tray portion includes a recess configured to receive the device.
8. The packaging system according to claim 7.
19. 17. The method of claim 16, wherein the first housing portion is separate from the second housing portion. The packaging system according to claim 1.
20. The first housing part is coupled to the second housing part via a slotted connection part. The packaging system of claim 16.
21. A substrate configured to receive the first housing portion and the second housing portion. The packaging system of claim 16 further comprising a portion.
22. The apparatus defines a third container and, prior to use in a third part of the tissue processing method, a third label identifying the third container, storing a third set of components associated with the third portion of the processing method; a third visual indicator associated with the third label of the device, the third visual indicator being configured to The packaging system of claim 16 further comprising a third housing portion including:
23. The first housing portion, the second housing portion, and the third housing portion 23. The packaging system of claim 22, further comprising a base configured to receive Tem.
24. A method for preparing a cell suspension using a device packaged in a housing. So, A first label disposed adjacent to a first container of the device and a first hand of the housing. Identifying a first match with a first visual indicator included in the housing; In response to identifying the first match, a first set of components is removed from the first housing portion. and associating the first container with the first set of components. performing a first part of the tissue processing method as provided herein; A second label disposed adjacent to the second container of the device and a second hand of the housing. identifying a second match with a second visual indicator included in the housing; and In response to identifying the second match, a second set of components is removed from the second housing portion. and associating the second container with the second set of components. performing a second part of the tissue processing method as set forth above; and A method comprising:
25. In response to identifying the first match, the first housing portion is moved to a sterilization area.
25. The method of claim 24, further comprising:
26. In response to identifying the second match, the second housing portion is moved to a sterilization area.
25. The method of claim 24, further comprising:
27. A third label disposed adjacent to a third container of the device and a third hand of the housing. identifying a third match with a third visual indicator included in the housing; and In response to identifying the third match, a third set of components is removed from the third housing portion. and associating the third container with the third set of components. performing a third part of the tissue processing method as set forth above; and The method of claim 24 further comprising:
28. performing a tissue manipulation portion of the tissue processing method on a preparation tray of the device; 25. The method of claim 24, comprising:
29. The first set of components includes a vial of sterile water, a syringe, and an enzyme vial. and wherein the first portion of the tissue processing method associated with the first container comprises: Preparing an enzyme mixture; delivering the enzyme mixture to the first container; 25. The method of claim 24, comprising:
30. removing the enzyme vial from the sterile pouch; disposing the enzyme vial in a recess defined in the first housing portion; 25. The method of claim 24, further comprising:
31. The second set of components includes a buffer vial and a syringe, The second portion of the tissue processing method associated with the container comprises: Drawing a volume of the buffer from the buffer vial into the syringe; delivering the volume of the buffer from the syringe to the second container; 25. The method of claim 24, comprising:
32. The third set of components includes a syringe and is associated with the third container. The third part of the tissue processing method comprises: Disintegrating the skin sample; generating a cell suspension comprising cells from the disintegrated skin sample; Drawing the cell suspension into the syringe; 26. The method of claim 25, comprising:
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